Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To demonstrate the efficacy of BTOS-HA as non inferior to Lumify for treating ocular redness in a population of adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) | Experimental |
| |
| Brimonidine tartrate ophthalmic solution 0.025% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTOS-HA | Drug | Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) | Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes | Assessed at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) | Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) after investigational drug instillation evaluated hierarchically at: 1 (+0.5) minute, 360 (+15) minutes and 480 (+15) minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
Ocular surgery within 3 months prior to screening and/or a history of refractive surgery within the past 6 months, and/ or planned surgery (ocular or systemic) during the trial period or within 30 days after the study period
Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection
Use any of the following disallowed medications during the period indicated prior to randomization or planned use during the study:
Have prior (within 7 days of beginning investigational drug) or currently active significant illness that could compromise participation, in the opinion of the investigator
Have prior (within 30 days of beginning investigational drug) or anticipated concurrent use of an investigational drug or device during the study period
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 (e.g., blepharitis, active ocular allergies, rosacea with peri-ocular involvement, uncontrolled diabetes, hypertension, or cardiovascular disease).
Have a diagnosis of ocular hypertension or glaucoma at screening
Any female who is nursing, lactating, pregnant, planning a pregnancy, or has a positive urine pregnancy test at Visit 2 (Day 1).
Any female of childbearing potential (FOCBP) who is unwilling to: a) agree to have urine pregnancy testing performed at Visit 2 (Day 1), and b) agree to use at least 1 medically acceptable form of birth control for at least 14 days prior to the first dose of study drug at Visit 2 (Day 1), throughout the study duration, and for 1 month after the last dose of investigational drug at Visit 4 (Day 29) NOTE: FOCBP include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
NOTE: Acceptable forms of birth control include:
NOTE: For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control when this is in line with the preferred and usual lifestyle of the subject; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial
Any male who is unwilling to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP)
NOTE: Acceptable forms of birth control include:
Without a vasectomy, must use condoms with spermicidal foam/gel/film/cream/suppository at least 14 days prior to the first dose of investigational drug at Visit 2 (Day 1) and throughout the study duration, and for 1 month after the last dose of the investigational drug at Visit 4 (Day 29)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 102 | Glendale | California | 91204 | United States | ||
| Site 104 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double masked
| Lumify® | Drug | Brimonidine tartrate ophthalmic solution 0.025%, administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart |
|
| Assessed at Visit 2 (Day 1) after investigational drug instillation evaluated hierarchically at: 1 (+0.5) minute, 360 (+15) minutes and 480 (+15) minutes |
| Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 3 (Day 15) | Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 3 (Day 15) 5 (+1) minutes and 15 (+1) minutes | Assessed at Visit 3 (Day 15) 5 (+1) minutes and 15 (+1) minutes |
| Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 4 (Day 29) | Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 4 (Day 29) 5 (+1) minutes and 15 (+1) minutes | Assessed at Visit 4 (Day 29) 5 (+1) minutes and 15 (+1) minutes |
| Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator after investigational drug instillation at Visit 2 (Day 1) | Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator after investigational drug instillation at Visit 2 (Day 1) evaluated hierarchically at 0.5 (+0.25) minute and 600 (+15) minutes | Assessed at Visit 2 (Day 1) evaluated hierarchically at 0.5 (+0.25) minute and 600 (+15) minutes |
| Newport Beach |
| California |
| 92663 |
| United States |
| Site 111 | Northbrook | Illinois | 60062 | United States |
| Site 109 | Pittsburg | Kansas | 66762 | United States |
| Site 106 | Louisville | Kentucky | 40206 | United States |
| Site 103 | Andover | Massachusetts | 01810 | United States |
| Site 108 | Garner | North Carolina | 27529 | United States |
| Site 107 | Shelby | North Carolina | 28150 | United States |
| Site 112 | Cranberry Township | Pennsylvania | 16066 | United States |
| Site 101 | Memphis | Tennessee | 38119 | United States |
| Site 105 | Smyrna | Tennessee | 37167 | United States |
| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided