Back to resultsA Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye (VELOS-3)
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
0.25% Tanfanercept Ophthalmic Solution
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Have a participant-reported history of dry eye for at least 6 months prior to Visit 1
- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
- Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1
- Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort & 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2
- Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm in at least one eye at Visits 1 and 2
- Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining in at least 1 of the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and 2
- Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival redness for dry eye scale in at least 1 eye at Visits 1 and 2
Exclusion Criteria:
- Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
- Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1
- Have any previous experience using TNF inhibitor ophthalmic solutions, such Tanfanercept Ophthalmic Solution
- Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)
- Be a woman who is pregnant, nursing or planning a pregnancy
Sites / Locations
- Cornea & Cataract Consultants of Arizona
- Global Research Management
- Eye Research Foundation, Inc.
- The Eye Care Institute - Butchertown Clinical Trials
- Andover Eye Associates: Raynham
- Center For Sight
- Oculus Research, Inc.
- Scott & Christie and Associates, PC
- Andover Eye Associates: Warwick
- Advancing Vision Research, LLC.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Placebo Comparator
Arm Label
Placebo Run-in
0.25% Tanfanercept Ophthalmic Solution
Placebo
Arm Description
Participants self-administered placebo ocular drops, twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period.
Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Outcomes
Primary Outcome Measures
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57
CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.
Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57
Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Secondary Outcome Measures
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12, and lower score indicated improvement.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for conjunctival regions was derived the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, temporal, and nasal regions. Total score ranged between 0 to 20, and lower score indicated improvement.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12,and lower score indicated improvement.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for conjunctival regions was derived as the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, nasal, and temporal regions. Total score ranged between 0 to 20, and lower score indicated improvement.
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8
It was evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.
Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8
The Schirmer test strip was placed in the lower temporal lid margin of each eye. Participants were instructed to close their eyes and after 5 minutes had elapsed, the length of moistened area of schirmer strip was recorded (millimeter [mm]) for each eye.
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8
Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it took to form micelles from the time that the eye is opened was noted.
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging
Participants rated ocular symptom of burning/stinging by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation
Participants rated ocular symptom of foreign body sensation by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching
Participants rated ocular symptom of itching by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision
Participants rated ocular symptom of blurred vision by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness
Participants rated ocular symptom of eye dryness by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia
Participants rated ocular symptom of photophobia by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain
Participants rated ocular symptom of pain by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8
OSDI was a simple 12-question survey that rated the severity of the participant's dry eye disease based on the symptoms. Each question response ranged from 0 to 4, where 0 = None of the Time, 1 = Some of the Time, 2 = Half of the Time, 3 = Most of the Time, and 4 = All of the Time. Total OSDI score = (Sum of all answered questions) * 25/ (number of questions answered); which ranged from 0 to 100, with higher score representing greater disability.
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8
It was assessed by the Ora Calibra® ocular discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Ora Calibra® Drop Comfort Assessment at Week 1
Ora Calibra® drop comfort scale ranged from 0 to 10. A score of 0 indicated comfortable and 10 indicated uncomfortable. Lower score indicated better comfort level. Immediately Upon Instillation, 1 Minute Post Instillation and 2 Minutes Post Instillation at Week 1
Full Information
NCT ID
NCT05109702
First Posted
October 27, 2021
Last Updated
October 19, 2023
Sponsor
HanAll BioPharma Co., Ltd.
Collaborators
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT05109702
Brief Title
A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
Acronym
VELOS-3
Official Title
A Phase 3, Multicenter, Randomized, Double Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% Compared to Placebo in Subjects With Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
May 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HanAll BioPharma Co., Ltd.
Collaborators
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Run-in
Arm Type
Other
Arm Description
Participants self-administered placebo ocular drops, twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period.
Arm Title
0.25% Tanfanercept Ophthalmic Solution
Arm Type
Experimental
Arm Description
Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Intervention Type
Drug
Intervention Name(s)
0.25% Tanfanercept Ophthalmic Solution
Other Intervention Name(s)
HL036
Intervention Description
Tanfanercept ophthalmic solution.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo vehicle solution.
Primary Outcome Measure Information:
Title
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57
Description
CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.
Time Frame
Baseline, Day 57 (Week 8)
Title
Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57
Description
Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline, Day 57 (Week 8)
Secondary Outcome Measure Information:
Title
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12, and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for conjunctival regions was derived the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, temporal, and nasal regions. Total score ranged between 0 to 20, and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12,and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for conjunctival regions was derived as the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining
Description
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, nasal, and temporal regions. Total score ranged between 0 to 20, and lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8
Description
It was evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8
Description
The Schirmer test strip was placed in the lower temporal lid margin of each eye. Participants were instructed to close their eyes and after 5 minutes had elapsed, the length of moistened area of schirmer strip was recorded (millimeter [mm]) for each eye.
Time Frame
Baseline; Weeks 2, 4, and 8
Title
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8
Description
Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it took to form micelles from the time that the eye is opened was noted.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging
Description
Participants rated ocular symptom of burning/stinging by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation
Description
Participants rated ocular symptom of foreign body sensation by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching
Description
Participants rated ocular symptom of itching by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision
Description
Participants rated ocular symptom of blurred vision by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness
Description
Participants rated ocular symptom of eye dryness by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia
Description
Participants rated ocular symptom of photophobia by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain
Description
Participants rated ocular symptom of pain by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8
Description
OSDI was a simple 12-question survey that rated the severity of the participant's dry eye disease based on the symptoms. Each question response ranged from 0 to 4, where 0 = None of the Time, 1 = Some of the Time, 2 = Half of the Time, 3 = Most of the Time, and 4 = All of the Time. Total OSDI score = (Sum of all answered questions) * 25/ (number of questions answered); which ranged from 0 to 100, with higher score representing greater disability.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8
Description
It was assessed by the Ora Calibra® ocular discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort
Description
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort
Description
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort
Description
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort
Description
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time Frame
Baseline; Weeks 1, 2, 4, and 8
Title
Ora Calibra® Drop Comfort Assessment at Week 1
Description
Ora Calibra® drop comfort scale ranged from 0 to 10. A score of 0 indicated comfortable and 10 indicated uncomfortable. Lower score indicated better comfort level. Immediately Upon Instillation, 1 Minute Post Instillation and 2 Minutes Post Instillation at Week 1
Time Frame
Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a participant-reported history of dry eye for at least 6 months prior to Visit 1
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1
Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort & 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2
Have a Schirmer's Test score of ≤ 10 millimeter (mm) and ≥ 1 mm in at least one eye at Visits 1 and 2
Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining in at least 1 of the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and 2
Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival redness for dry eye scale in at least 1 eye at Visits 1 and 2
Exclusion Criteria:
Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1
Have any previous experience using TNF inhibitor ophthalmic solutions, such Tanfanercept Ophthalmic Solution
Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)
Be a woman who is pregnant, nursing or planning a pregnancy
Facility Information:
Facility Name
Cornea & Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Global Research Management
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Eye Research Foundation, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
The Eye Care Institute - Butchertown Clinical Trials
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Andover Eye Associates: Raynham
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Center For Sight
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Oculus Research, Inc.
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Andover Eye Associates: Warwick
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Advancing Vision Research, LLC.
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
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