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Dry Eye Disease Study With Brimonidine

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Brimonidine

Brimonidine Mono Therapy

sodium carboxymethylcellulose

Corticosteroid Eye Drop

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged 18 years or older.
Sign and date informed consent form approved by the IRB
History of Dry Eye Disease
Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:
i. Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes
Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits
Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye
Women who satisfy one of the following:
1. 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, OR
2. Are post-menopausal or have undergone a sterilization procedure

Exclusion Criteria:

Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)
Use of contact lenses
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, institutionalized individuals, or others who may be considered vulnerable populations
Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months
Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic solution 5% (Xiidra™) within 30 days prior to Screening visit
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

Chicago Cornea Consultants
Brenart Eye Clinic
The Eye Institute of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Drug Arm #1

Study Drug Arm #2

Control Arm

Arm Description

Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks

Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks

Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks

Outcomes

Primary Outcome Measures

Tolerance of Test Substance Visual Analogue Scale (VAS) Score

Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).

Secondary Outcome Measures

Full Information

NCT ID

NCT03418727

First Posted

October 10, 2017

Last Updated

June 10, 2022

Sponsor

Ocugen

1. Study Identification

Unique Protocol Identification Number

NCT03418727

Brief Title

Dry Eye Disease Study With Brimonidine

Official Title

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

September 6, 2017 (Actual)

Primary Completion Date

March 29, 2018 (Actual)

Study Completion Date

March 29, 2018 (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

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).

Detailed Description

Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).

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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Drug Arm #1

Arm Type

Experimental

Arm Description

Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks

Arm Title

Study Drug Arm #2

Arm Type

Experimental

Arm Description

Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks

Arm Title

Control Arm

Arm Type

Placebo Comparator

Arm Description

Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Brimonidine

Intervention Description

Two products delivered in sequence twice daily.

Intervention Type

Drug

Intervention Name(s)

Brimonidine Mono Therapy

Intervention Description

Brimonidine given twice daily along with placebo drops

Intervention Type

Drug

Intervention Name(s)

sodium carboxymethylcellulose

Intervention Description

Placebo given twice daily.

Intervention Type

Drug

Intervention Name(s)

Corticosteroid Eye Drop

Intervention Description

Eye drop to be administered after Brimonidine in treatment arm 1

Primary Outcome Measure Information:

Title

Tolerance of Test Substance Visual Analogue Scale (VAS) Score

Description

Time Frame

Days 1, 28, 56, and 84

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18 years or older. Sign and date informed consent form approved by the IRB History of Dry Eye Disease Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits: i. Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye Women who satisfy one of the following: 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, OR Are post-menopausal or have undergone a sterilization procedure Exclusion Criteria: Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK) Use of contact lenses 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, institutionalized individuals, or others who may be considered vulnerable populations Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic solution 5% (Xiidra™) within 30 days prior to Screening visit 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

Chicago Cornea Consultants

City

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

Facility Name

Brenart Eye Clinic

City

Yorkville

State/Province

Illinois

ZIP/Postal Code

60560

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

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Dry Eye Disease Study With Brimonidine

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