Dry Eye Disease Study With Brimonidine

Dry Eye Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418727
• Other study ID #: OCU-310-DED-2017
• Status: Completed
• Phase: Phase 2
• Start date: September 6, 2017
• Est. completion date: March 29, 2018

Study information

• Verified date: June 2022
• Source: Ocugen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Brimonidine
Two products delivered in sequence twice daily.
• Brimonidine Mono Therapy
Brimonidine given twice daily along with placebo drops
• sodium carboxymethylcellulose
Placebo given twice daily.
• Corticosteroid Eye Drop
Eye drop to be administered after Brimonidine in treatment arm 1

Locations

Country	Name	City	State
United States	Chicago Cornea Consultants	Hoffman Estates	Illinois
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	Brenart Eye Clinic	Yorkville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ocugen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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