Dry Eye Disease Study With Brimonidine

NCT03418727 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OCU-310-DED-2017
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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).

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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).

  Days 1, 28, 56, and 84

Study Arms (3)

Study Drug Arm #1

EXPERIMENTAL

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

Drug: Brimonidine; Drug: Corticosteroid Eye Drop

Study Drug Arm #2

EXPERIMENTAL

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

Drug: Brimonidine Mono Therapy

Control Arm

PLACEBO COMPARATOR

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

Drug: sodium carboxymethylcellulose

Interventions

Brimonidine DRUG

Two products delivered in sequence twice daily.

Study Drug Arm #1

Brimonidine Mono Therapy DRUG

Brimonidine given twice daily along with placebo drops

Study Drug Arm #2

sodium carboxymethylcellulose DRUG

Placebo given twice daily.

Control Arm

Corticosteroid Eye Drop DRUG

Eye drop to be administered after Brimonidine in treatment arm 1

Study Drug Arm #1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocugen: lead

Study Sites (3)

Chicago Cornea Consultants

Hoffman Estates, Illinois, 60169, United States

Location

Brenart Eye Clinic

Yorkville, Illinois, 60560, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Brimonidine Tartrate; Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Vijay Tammara, VP, Strategic Regulatory Operations
• Organization: Ocugen

Vijay.tammara@ocugen.com

484-328-4751

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: February 1, 2018
• Study Start: September 6, 2017
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: July 6, 2022
• Results First Posted: July 6, 2022

Record last verified: 2022-06

Locations

US (3)