search
Back to results

Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BRM421
Placebo
Sponsored by
BRIM Biotechnology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Research Foundation
  • Midwest Cornea Associates, LLC
  • Andover Eye Associates
  • Total Eye Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BRM421 Ophthalmic Solution

Placebo

Arm Description

A topical solution of BRIM421 ophthalmic drops

A vehicle ophthalmic drops

Outcomes

Primary Outcome Measures

Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. Ora Calibra® Scale from 0 to 4 with the use of half grade (0.5) increments, where grade 0 = None and 4 = Severe. Regions assessed were the central, superior, inferior, temporal, and nasal. Total corneal staining score was the sum of all five regions. Analyses were for study eye only.
Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Ocular dryness from the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire was assessed at the subject level in regard to how both eyes felt. The Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire was used, which included rating the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranged from 0 to 5, where 0 = None and 5 = Worst.

Secondary Outcome Measures

Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 14, Using Visual Analog Scale (VAS)
Visual analog scale (VAS) was measured by asking subjects to rate each ocular symptom due to ocular dryness by placing a vertical mark on a horizontal line of length 100 mm to indicate the level of discomfort where 0 mm = No Discomfort and 100 mm = Maximal Discomfort. Symptoms assessed were burning/stinging, itching, foreign body sensation, blurred vision, eye dryness, photophobia, and pain.

Full Information

First Posted
April 9, 2020
Last Updated
September 24, 2021
Sponsor
BRIM Biotechnology Inc.
Collaborators
ORA, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04343287
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
June 23, 2020 (Actual)
Study Completion Date
June 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BRIM Biotechnology Inc.
Collaborators
ORA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double Masking
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRM421 Ophthalmic Solution
Arm Type
Active Comparator
Arm Description
A topical solution of BRIM421 ophthalmic drops
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A vehicle ophthalmic drops
Intervention Type
Drug
Intervention Name(s)
BRM421
Intervention Description
The active control with BRM421 solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The vehicle solution
Primary Outcome Measure Information:
Title
Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14
Description
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. Ora Calibra® Scale from 0 to 4 with the use of half grade (0.5) increments, where grade 0 = None and 4 = Severe. Regions assessed were the central, superior, inferior, temporal, and nasal. Total corneal staining score was the sum of all five regions. Analyses were for study eye only.
Time Frame
2 weeks
Title
Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Description
Ocular dryness from the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire was assessed at the subject level in regard to how both eyes felt. The Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire was used, which included rating the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranged from 0 to 5, where 0 = None and 5 = Worst.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 14, Using Visual Analog Scale (VAS)
Description
Visual analog scale (VAS) was measured by asking subjects to rate each ocular symptom due to ocular dryness by placing a vertical mark on a horizontal line of length 100 mm to indicate the level of discomfort where 0 mm = No Discomfort and 100 mm = Maximal Discomfort. Symptoms assessed were burning/stinging, itching, foreign body sensation, blurred vision, eye dryness, photophobia, and pain.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blair Boehmer, MD
Organizational Affiliation
Midwest Cornea Associates, LLC.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Wirta, MD
Organizational Affiliation
Eye Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene B McLaurin, MD
Organizational Affiliation
Total Eye Care, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Midwest Cornea Associates, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

We'll reach out to this number within 24 hrs