Safety and Efficacy of BRM421 for Dry Eye Syndrome

• Sponsor: BRIM Biotechnology Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03066219
• Collaborator: (none)
• Enrollment: 157
• Locations: 2
• Arms: 2
• Actual Duration (Months): 4.6
• Patients Per Site: 78.5
• Patients Per Site Per Month: 16.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: BRM421; Drug: Placebo	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 7, 2017
• Actual Primary Completion Date: May 20, 2017
• Actual Study Completion Date: Jun 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BRM421 Ophthalmic Solution The active control with BRM421 solution	Drug: BRM421; A topical solution of BRIM421 ophthalmic drops
Placebo Comparator: Placebo The vehicle solution	Drug: Placebo; vehicle ophthalmic drops

Outcome Measures

Primary Outcome Measures

1. Sign: Corneal fluorescein staining score [Up to 4 weeks]

2. Symptom: Ocular discomfort score [Up to 4 weeks]

Secondary Outcome Measures

1. Tear film break-up time [Up to 4 weeks]

2. Conjunctival Redness [Up to 4 weeks]

3. Ocular Surface Disease Index (OSDI)© [Up to 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Maine Eye Care	Lewiston	Maine	United States	04240
2	Andover Eye Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• BRIM Biotechnology Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BRIM Biotechnology Inc.
• ClinicalTrials.gov Identifier: NCT03066219
• Other Study ID Numbers: BRM421-16-C001-PR
• First Posted: Feb 28, 2017
• Last Update Posted: Nov 22, 2017
• Last Verified: Nov 1, 2017

• 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; Syndrome

Study Results

No Results Posted as of Nov 22, 2017