Dry Eye Syndrome
Conditions
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, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).
Interventions
DRUGBRM421
0.03%(w/v) BRIM421 ophthalmic solution
DRUGPlacebo
vehicle ophthalmic drops
Sponsors
BRIM Biotechnology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sign: Corneal Fluorescein Staining Score | change from baseline to week 4 | The staining was graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The ocular surface was divided into three regions, including superior, central and inferior region. The following scale was used to grade staining of the each region. Half (0.5) grade increments may be used. The total score of corneal fluorescein staining was calculated as the sum of three regions, the score range is 0 (minimum) to 12 (maximum). None 0 = no staining Trace 1 = occasional Mild 2 = countable Moderate 3 = uncountable, but not confluent Severe 4 = confluent |
| Symptom: Ocular Discomfort Score | change from baseline to week 4 | Ocular discomfort scores was subjectively graded by the subjects according to the following Ora Calibra® Ocular Discomfort Scale, rating each eye separately, the score range is 0 (minimum) to 4 (maximum). 0 = no discomfort 1. = intermittent awareness 2. = constant awareness 3. = intermittent discomfort 4. = constant discomfort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Break-up Time | change from baseline to week 4 | The examiner was instilled 5 uL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit-lamp, the examiner monitored the integrity of the tear film, noting the time (seconds) it takes to form micelles from the time that the eye is opened. |
| Conjunctival Redness | change from baseline to week 4 | Conjunctival redness was graded according to the following scale: Half (0.5) unit increments may be used. None 0 = Normal, without vasodilation Trace 1 = Trace ciliary or conjunctival vasodilation Mild 2 = Broad ciliary vasodilation; Moderate 3 = Broad ciliary and slight, horizontal conjunctival vasodilation Severe 4 = Broad ciliary and prominent, horizontal conjunctival vasodilation |
| Ocular Surface Disease Index (OSDI)© | change from baseline to week 4 | OSDI scores was subjectively graded by the subjects according to the Ocular Surface and Disease Index (OSDI) Scale. Patients scored each question from 0 to 4 (higher score means more severe), and the OSDI score is the sum of total 12 questions. The score range is 0 (minimum) to 48 (maximum). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGail Torkildsen, MD
Andover Eye Associates
PRINCIPAL_INVESTIGATORJohn Lonsdale, MD
Central Maine Eye Care
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 75 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants |
| Age, Continuous | 62.7 years STANDARD_DEVIATION 12.57 |
| Burning | 78 Participants |
| Dryness | 78 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Grittiness | 79 Participants |
| Ocular Discomfort | 79 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment United States | 79 Participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 25 Participants |
| Stinging | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 79 |
| other Total, other adverse events | 4 / 78 | 3 / 79 |
| serious Total, serious adverse events | 0 / 78 | 0 / 79 |
Outcome results
None listed