Clinical trial NCT03418727: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Ocugen
Sponsor class: INDUSTRY
First posted: 2018-02-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Tolerance of Test Substance Visual Analogue Scale (VAS) Score
timeFrame: Days 1, 28, 56, and 84
Secondary outcomes:
Other outcomes:
Locations:
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Yorkville
country: United States
facility: Brenart Eye Clinic
state: Illinois
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
References: