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A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants

Primary Purpose

Dry Eye Syndromes

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IC265 Ophthalmic Solution 1%
Placebo Ophthalmic Solution (Vehicle)
Sponsored by
Iacta Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be at least 18 years of age; Provide written informed consent Have a reported or documented 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 Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at least one symptom at Visits 1 and 2 Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2 Have a pre-CAE conjunctival redness score ≥ 1 according to the Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g. inferior, superior, or central) at Visits 1 and 2 Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of the inferior, superior, and central regions at Visits 1 and 2 Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions at Visits 1 and 2 Demonstrate a response to the CAE at Visits 1 and 2 as defined by: Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE exposure Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure (if a subject has an ocular discomfort rating of 3 at time = 0 for an eye, s/he must report an ocular discomfort rating of 4 for two consecutive measurements for that eye) Note: a subject cannot have an ocular discomfort score of 4 at time = 0) Exclusion Criteria: Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation or active ocular allergies that require therapeutic treatment Have any clinically significant (CS) posterior chamber findings, or a history of such findings/disorders, that may include exudative (i.e., wet) age-related macular degeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocular hypertension, or any other retinal or optic nerve disease/disorder that require therapeutic treatment and/or in the opinion of the Investigator may interfere with study parameters Have worn contact lenses within 48 hours prior to Visit 1 or anticipate using contact lenses during the study Have laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery and/or any other ocular surgical procedure within 12 months prior to Visit 1; or have any ocular surgical procedure scheduled to be conducted during the study period Have had any surgeries of the ocular surface or lid in the past 6 months Have a history of lacrimal duct obstruction in either eye within 12 months prior to Visit 1 Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1 or anticipate their use during the study period Have permanent punctal plugs inserted or removed - including falling out - or have had surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate any such event at any time during the study period Use any of the following treatments in the period indicated before Visit 1 or anticipate their use at any time during the study

Sites / Locations

  • Iacta Selected SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IC265 Ophthalmic Solution 1%

Placebo Ophthalmic Solution (Vehicle)

Arm Description

1 drop will be instilled in each eye twice daily.

1 drop will be instilled in each eye twice daily.

Outcomes

Primary Outcome Measures

Fluorescein staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score
The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
Ocular discomfort and dry eye symptoms
Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.
Lissamine green staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score
The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
Tear film break-up time (TFBUT)
With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are > 2 seconds apart and are each < 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged.
Conjunctival Redness
Conjunctival Redness at Visits 3, 4 (pre-CAE, post-CAE, and pre- to post- CAE), and 5 (pre-CAE, post-CAE, and pre- to post-CAE), and mean change from baseline Visit 2 (Day 1) pre-CAE to Visit 5 (Day 85) pre-CAE
Ocular Surface Disease Index (OSDI)©
Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100.
Schirmer's test
Ocular discomfort during CAE
Daily Diary Symptom Score

Secondary Outcome Measures

Full Information

First Posted
August 8, 2023
Last Updated
October 20, 2023
Sponsor
Iacta Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05992922
Brief Title
A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants
Official Title
A Phase 2, Single-Center, Randomized, Double- Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution 1% in Subjects Diagnosed With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iacta Pharmaceuticals

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
This study will evaluate the safety, tolerability and efficacy of IC265 compared to vehicle in participants with signs and symptoms dry eye disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IC265 Ophthalmic Solution 1%
Arm Type
Experimental
Arm Description
1 drop will be instilled in each eye twice daily.
Arm Title
Placebo Ophthalmic Solution (Vehicle)
Arm Type
Placebo Comparator
Arm Description
1 drop will be instilled in each eye twice daily.
Intervention Type
Drug
Intervention Name(s)
IC265 Ophthalmic Solution 1%
Intervention Description
1 drop will be instilled in each eye twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo Ophthalmic Solution (Vehicle)
Intervention Description
1 drop will be instilled in each eye twice a day
Primary Outcome Measure Information:
Title
Fluorescein staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score
Description
The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
Time Frame
Days 15, 43 and 85
Title
Ocular discomfort and dry eye symptoms
Description
Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.
Time Frame
Days 15, 43 and 85
Title
Lissamine green staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score
Description
The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
Time Frame
Days 15, 43 and 85
Title
Tear film break-up time (TFBUT)
Description
With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are > 2 seconds apart and are each < 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged.
Time Frame
Days 15, 43 and 85
Title
Conjunctival Redness
Description
Conjunctival Redness at Visits 3, 4 (pre-CAE, post-CAE, and pre- to post- CAE), and 5 (pre-CAE, post-CAE, and pre- to post-CAE), and mean change from baseline Visit 2 (Day 1) pre-CAE to Visit 5 (Day 85) pre-CAE
Time Frame
Days 15, 43 and 85 and mean change from Day 1 to Day 85
Title
Ocular Surface Disease Index (OSDI)©
Description
Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100.
Time Frame
Days 15, 43 and 85
Title
Schirmer's test
Time Frame
Days 15, 43 and 85
Title
Ocular discomfort during CAE
Time Frame
Days 43 and 85
Title
Daily Diary Symptom Score
Time Frame
Daily Diary completed from Day 1 through Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age; Provide written informed consent Have a reported or documented 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 Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at least one symptom at Visits 1 and 2 Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2 Have a pre-CAE conjunctival redness score ≥ 1 according to the Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g. inferior, superior, or central) at Visits 1 and 2 Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of the inferior, superior, and central regions at Visits 1 and 2 Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions at Visits 1 and 2 Demonstrate a response to the CAE at Visits 1 and 2 as defined by: Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE exposure Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure (if a subject has an ocular discomfort rating of 3 at time = 0 for an eye, s/he must report an ocular discomfort rating of 4 for two consecutive measurements for that eye) Note: a subject cannot have an ocular discomfort score of 4 at time = 0) Exclusion Criteria: Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation or active ocular allergies that require therapeutic treatment Have any clinically significant (CS) posterior chamber findings, or a history of such findings/disorders, that may include exudative (i.e., wet) age-related macular degeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocular hypertension, or any other retinal or optic nerve disease/disorder that require therapeutic treatment and/or in the opinion of the Investigator may interfere with study parameters Have worn contact lenses within 48 hours prior to Visit 1 or anticipate using contact lenses during the study Have laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery and/or any other ocular surgical procedure within 12 months prior to Visit 1; or have any ocular surgical procedure scheduled to be conducted during the study period Have had any surgeries of the ocular surface or lid in the past 6 months Have a history of lacrimal duct obstruction in either eye within 12 months prior to Visit 1 Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1 or anticipate their use during the study period Have permanent punctal plugs inserted or removed - including falling out - or have had surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate any such event at any time during the study period Use any of the following treatments in the period indicated before Visit 1 or anticipate their use at any time during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iacta Pharma
Phone
714-330-8532
Email
sj@iactapharma.com
Facility Information:
Facility Name
Iacta Selected Site
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants

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