Clinical trial NCT04343287: Safety and Efficacy of BRM421 for Dry Eye Syndrome 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndrome
Lead sponsor: BRIM Biotechnology Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2020-04-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).

Eligibility criteria: 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

Primary outcomes:
measure: Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14
timeFrame: 2 weeks
measure: Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
timeFrame: 2 weeks
Secondary outcomes:
measure: Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 14, Using Visual Analog Scale (VAS)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Indianapolis
country: United States
facility: Midwest Cornea Associates, LLC
state: Indiana
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Cornea Associates, LLC.
name: Blair Boehmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Research Foundation
name: David Wirta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Total Eye Care, PA
name: Eugene B McLaurin, MD
role: PRINCIPAL_INVESTIGATOR
References: