Safety and Efficacy of BRM421 for Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

Official title:

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066219
• Other study ID #: BRM421-16-C001-PR
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2017
• Last updated: November 20, 2017
• Start date: February 7, 2017
• Est. completion date: June 28, 2017

Study information

• Verified date: November 2017
• Source: BRIM Biotechnology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Description:

This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: June 28, 2017
• Est. primary completion date: May 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years of age;

• Provide written informed consent;

• Have a reported history of dry eye for at least 6 months prior to enrollment;

• Have a history of use of eye drops

Exclusion Criteria:

• Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;

• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;

• Have used any eye drops within 2 hours of Visit 1;

• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;

• Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• BRM421
A topical solution of BRIM421 ophthalmic drops
• Placebo
vehicle ophthalmic drops

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Central Maine Eye Care	Lewiston	Maine

Sponsors (1)

Lead Sponsor	Collaborator
BRIM Biotechnology Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sign: Corneal fluorescein staining score		Up to 4 weeks
Primary	Symptom: Ocular discomfort score		Up to 4 weeks
Secondary	Tear film break-up time		Up to 4 weeks
Secondary	Conjunctival Redness		Up to 4 weeks
Secondary	Ocular Surface Disease Index (OSDI)©		Up to 4 weeks