Back to resultsStudy of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brimonidine Tartrate
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older.
- Sign and date informed consent form approved by the IRB
- History of Dry Eye Disease for ≥6 months
Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):
- Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and
- Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes
- Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
- Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
- Women who satisfy one of the following:
8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure
Exclusion Criteria:
- Allergic to brimonidine or any similar products, or excipients of brimonidine
- Use of contact lenses within 14 days prior to Screening visit or planned use during study
- Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
- Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
- Intraocular pressure <5 mmHg or >22 mmHg in either eye
- Active ocular infection or history of ocular herpetic keratitis
- History of neurotrophic keratitis or ocular neuropathic pain
- Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
- Punctal occlusion within 3 months prior to Screening visit or during study
- Corneal epithelial defect larger than 1 mm2 in either eye
- Have active drug/alcohol dependence or abuse history
- Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
- Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
- Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit or planned change during study
- In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
- Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
Sites / Locations
- Aesthetic Eye Care Institute/David Wirta, MD and Associates
- Martel Medical Eye Group
- Rand Eye Institute
- Chicago Cornea Consultants
- Heart of America Eye Care, P. A.
- Ophthalmology Associates
- Apex Eye- Kenwood
- Apex Eye-Montgomery
- Abrams Eye Center
- Scott and Christie Eyecare Associates
- Total Eye Care
- Toyos Clinic
- Midtown Eye Physicans & Associates
- Advanced Laser Vision & Surgical Institute
- Revolution Research, Inc; Lake Travis Eye and Laser Center
- The Eye Institute of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OCU-310
Placebos
Arm Description
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks
Outcomes
Primary Outcome Measures
Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
Secondary Outcome Measures
Change From Baseline to 2 Weeks (Day 14) in SANDE Score
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03785340
Brief Title
Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)
Official Title
A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocugen
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 evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).
Detailed Description
Dry eye disease (DED) is a common ocular disorder involving the aberrant production and instability of tear film, which results in damage to the ocular surface and is correlated with symptoms of ocular discomfort.
This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 25 centers. Upon meeting the eligibility criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or ophthalmic buffered saline (placebo).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCU-310
Arm Type
Experimental
Arm Description
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks
Arm Title
Placebos
Arm Type
Placebo Comparator
Arm Description
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate
Other Intervention Name(s)
OCU-310
Intervention Description
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Ophthalmic buffered saline solution
Intervention Description
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
Description
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Time Frame
Baseline, 4 weeks (Day 28)
Title
Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
Description
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
Time Frame
Baseline, 4 Weeks (Day 28)
Secondary Outcome Measure Information:
Title
Change From Baseline to 2 Weeks (Day 14) in SANDE Score
Description
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Time Frame
Baseline, 2 weeks (Day 14)
Title
Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores
Description
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
Time Frame
Baseline, 2 Weeks (Day 14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older.
Sign and date informed consent form approved by the IRB
History of Dry Eye Disease for ≥6 months
Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):
Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and
Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes
Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
Women who satisfy one of the following:
8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure
Exclusion Criteria:
Allergic to brimonidine or any similar products, or excipients of brimonidine
Use of contact lenses within 14 days prior to Screening visit or planned use during study
Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
Intraocular pressure <5 mmHg or >22 mmHg in either eye
Active ocular infection or history of ocular herpetic keratitis
History of neurotrophic keratitis or ocular neuropathic pain
Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
Punctal occlusion within 3 months prior to Screening visit or during study
Corneal epithelial defect larger than 1 mm2 in either eye
Have active drug/alcohol dependence or abuse history
Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit or planned change during study
In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
Facility Information:
Facility Name
Aesthetic Eye Care Institute/David Wirta, MD and Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Martel Medical Eye Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Rand Eye Institute
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Chicago Cornea Consultants
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Heart of America Eye Care, P. A.
City
Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Apex Eye- Kenwood
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Apex Eye-Montgomery
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Scott and Christie Eyecare Associates
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Toyos Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Midtown Eye Physicans & Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Advanced Laser Vision & Surgical Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Revolution Research, Inc; Lake Travis Eye and Laser Center
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)
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