Dry Eye Disease Study With Brimonidine

• ClinicalTrials.gov Identifier: NCT03418727
• Recruitment Status: Completed
• First Posted: February 1, 2018
• Last Update Posted: July 16, 2020
• Sponsor: Ocugen
• Information provided by (Responsible Party): Ocugen

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).

Condition or disease	Intervention/treatment	Phase
Dry Eye	Drug: Brimonidine; Drug: Brimonidine Mono Therapy; Drug: sodium carboxymethylcellulose; Drug: Corticosteroid Eye Drop	Phase 2

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: September 6, 2017
• Actual Primary Completion Date: March 29, 2018
• Actual Study Completion Date: March 29, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study Drug Arm #1; Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks	Drug: Brimonidine; Two products delivered in sequence twice daily.; Drug: Corticosteroid Eye Drop; Eye drop to be administered after Briomonidine in treatment arm 1
Experimental: Study Drug Arm #2; Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks	Drug: Brimonidine Mono Therapy; Brimonidine given twice daily along with placebo drops
Placebo Comparator: Control Arm; 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; Placebo given twice daily.

Outcome Measures

Primary Outcome Measures :

1. Main Objective (Tolerability) [ Time Frame: Baseline - Day 84 ]
   Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analogue 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, and Day 84,. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Aged 18 years or older.
2. Sign and date informed consent form approved by the IRB
3. History of Dry Eye Disease

4. 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

5. Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits
6. Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye

7. 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:

1. Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)
2. Use of contact lenses
3. Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
4. Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
5. Intraocular pressure <5 mmHg or >22 mmHg in either eye
6. Active ocular infection or history of ocular herpetic keratitis
7. History of neurotrophic keratitis or ocular neuropathic pain
8. Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
9. Punctal occlusion within 3 months prior to Screening visit or during study
10. Corneal epithelial defect larger than 1 mm2 in either eye
11. Have active drug/alcohol dependence or abuse history
12. Are neonates, pregnant/lactating women, children, institutionalized individuals, or others who may be considered vulnerable populations
13. Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months
14. Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic solution 5% (Xiidra™) within 30 days prior to Screening visit
15. In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
16. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol

Contacts and Locations

Locations

United States, Illinois

Chicago Cornea Consultants

Hoffman Estates, Illinois, United States, 60169

Brenart Eye Clinic

Yorkville, Illinois, United States, 60560

United States, Utah

The Eye Institute of Utah

Salt Lake City, Utah, United States, 84107

Sponsors and Collaborators

Ocugen

More Information

• Responsible Party: Ocugen
• ClinicalTrials.gov Identifier: NCT03418727
• Other Study ID Numbers: OCU-310-DED-2017
• First Posted: February 1, 2018
• Last Update Posted: July 16, 2020
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Brimonidine Tartrate; Carboxymethylcellulose Sodium; Ophthalmic Solutions; Pharmaceutical Solutions; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Laxatives; Gastrointestinal Agents