Ocular Redness
Conditions
Brief summary
This is a multi-center, double-masked, randomized, active-controlled, parallel-group, efficacy and safety study that will enroll 386 participants at up to six clinical sites. Participants with ocular redness will be randomized to receive either brimonidine tartrate ophthalmic solution 0.025%, preservative-free formulation, or Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will be treated with study drug for approximately 4 weeks.
Interventions
DRUGBrimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
DRUGLumify® (brimonidine tartrate ophthalmic solution 0.025%)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
Sponsors
Bausch & Lomb Incorporated
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
1. Be at least 18 years of age at the time of Informed Consent signing of either gender and any race or ethnicity; 2. Provide written informed consent and sign the HIPAA form; 3. Be willing and able to follow all instructions and attend all study visits; 4. Have a history of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use OTC vasoconstrictors for redness relief; 5. Be able to self-administer eye drops satisfactorily or have a subject's care provider at home1 routinely available for this purpose; 6. (If female and of childbearing potential) agree to have urine pregnancy testing performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and must agree to use at least 1 medically acceptable form of birth control2 throughout the study duration and for at least 14 days prior to the first dose of study drug (Visit 1) and for 1 month after the last dose of investigational drug. Note: Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); 7. (If male and with female partner of childbearing potential) must use at least 1 medically acceptable form of birth control3; 8. A calculated best-corrected (if necessary) visual acuity of 0.3 logMAR or better in each eye, as measured using an ETDRS chart; 9. At Visit 1 (Baseline), show a baseline redness score \>1 unit (ie, greater than 1 unit) in both eyes on a 0 to 4 unit scale as scored by the Investigator using the Investigator Ocular Redness Scale; 10. Have stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention during the study).
Exclusion criteria
1. Have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol; 2. Have had ocular surgical intervention within 3 months prior to screening or during the study and/or a history of refractive surgery within the past 6 months; 3. Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit; 4. Use any of the following disallowed medications during the period indicated prior to screening and for the duration of the study: * All topical ophthalmic agents including artificial tear products, eye whiteners (e.g., vasoconstrictors), ocular decongestants, ocular antihistamines, ocular corticosteroids, dilating drops, (excluding dilated ophthalmoscopy exam at Visit 1) and contact lenses: 5 days * Systemic antihistamines or decongestants: 7 days * Systemic corticosteroids or cancer chemotherapy, and/or any other systemic medications which the investigator feels may confound study data, or interfere with subject's study participation: 14 days 5. Have prior (within 7 days of beginning investigational drug) or currently active significant illness that could compromise participation, in the opinion of the investigator; 6. Have prior (within 30 days of beginning investigational drug) or anticipated concurrent use of an investigational drug or device during the study period; 7. Have an ocular or systemic condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation; 8. Have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period; 9. Be currently breast feeding or planning to breast feed during the study period or is a female who is currently pregnant, is planning a pregnancy, or has a positive urine pregnancy test at Visit 1; 10. Have a diagnosis of ocular hypertension or glaucoma at screening; 11. Have symptoms that, in the opinion of the investigator, may be associated with COVID-19 or in the last 14 days came into contact with someone diagnosed with COVID-19.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Redness | Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation. | Ocular redness score evaluated by the investigator from 5 minutes to 240 minutes after investigational drug instillation (0-4 unit scale, where 0 = None and 4 = Extremely severe). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brimonidine Tartrate Preservation-free Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks. | 190 |
| Lumify® Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%): Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks. | 190 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued | 25 | 11 |
Baseline characteristics
| Characteristic | Lumify® | Total | Brimonidine Tartrate Preservation-free |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 84 Participants | 160 Participants | 76 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants | 220 Participants | 114 Participants |
| Age, Continuous | 59.5 years STANDARD_DEVIATION 14.76 | 59 years STANDARD_DEVIATION 14.7 | 58.4 years STANDARD_DEVIATION 14.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 29 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 173 Participants | 351 Participants | 178 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 89 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 138 Participants | 276 Participants | 138 Participants |
| Region of Enrollment United States | 190 Participants | 380 Participants | 190 Participants |
| Sex: Female, Male Female | 125 Participants | 267 Participants | 142 Participants |
| Sex: Female, Male Male | 65 Participants | 113 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 188 | 0 / 190 |
| other Total, other adverse events | 13 / 188 | 18 / 190 |
| serious Total, serious adverse events | 0 / 188 | 1 / 190 |
Outcome results
Primary
Ocular Redness
Ocular redness score evaluated by the investigator from 5 minutes to 240 minutes after investigational drug instillation (0-4 unit scale, where 0 = None and 4 = Extremely severe).
Time frame: Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Tartrate Preservation-free | Ocular Redness | 30 minutes Post Instillation | 0.42 score on a scale | Standard Error 0.038 |
| Brimonidine Tartrate Preservation-free | Ocular Redness | 5 minutes Post Instillation | 0.46 score on a scale | Standard Error 0.039 |
| Brimonidine Tartrate Preservation-free | Ocular Redness | 15 minutes Post Instillation | 0.40 score on a scale | Standard Error 0.038 |
| Brimonidine Tartrate Preservation-free | Ocular Redness | 60 minutes Post Instillation | 0.47 score on a scale | Standard Error 0.04 |
| Brimonidine Tartrate Preservation-free | Ocular Redness | 90 minutes Post Instillation | 0.54 score on a scale | Standard Error 0.043 |
| Brimonidine Tartrate Preservation-free | Ocular Redness | 120 minutes Post Instillation | 0.64 score on a scale | Standard Error 0.046 |
| Brimonidine Tartrate Preservation-free | Ocular Redness | 180 minutes Post Instillation | 0.79 score on a scale | Standard Error 0.046 |
| Brimonidine Tartrate Preservation-free | Ocular Redness | 240 minutes Post Instillation | 0.99 score on a scale | Standard Error 0.047 |
| Lumify® | Ocular Redness | 240 minutes Post Instillation | 0.98 score on a scale | Standard Error 0.049 |
| Lumify® | Ocular Redness | 90 minutes Post Instillation | 0.58 score on a scale | Standard Error 0.044 |
| Lumify® | Ocular Redness | 5 minutes Post Instillation | 0.53 score on a scale | Standard Error 0.041 |
| Lumify® | Ocular Redness | 180 minutes Post Instillation | 0.84 score on a scale | Standard Error 0.049 |
| Lumify® | Ocular Redness | 15 minutes Post Instillation | 0.49 score on a scale | Standard Error 0.041 |
| Lumify® | Ocular Redness | 30 minutes Post Instillation | 0.50 score on a scale | Standard Error 0.041 |
| Lumify® | Ocular Redness | 120 minutes Post Instillation | 0.67 score on a scale | Standard Error 0.046 |
| Lumify® | Ocular Redness | 60 minutes Post Instillation | 0.52 score on a scale | Standard Error 0.041 |