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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brimonidine tartrate preservation-free | Experimental | Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation |
|
| Lumify® | Active Comparator | Lumify® (brimonidine tartrate ophthalmic solution 0.025%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation. |
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Inclusion Criteria:
Exclusion Criteria:
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;
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;
Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
Use any of the following disallowed medications during the period indicated prior to screening and for the duration of 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;
Have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period;
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;
Have a diagnosis of ocular hypertension or glaucoma at screening;
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.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Donatello | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 04 | Colorado Springs | Colorado | 80907 | United States | ||
| Bausch Site 05 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40711722 | Derived | Toyos M, DiVito M, Messmer EM, McGee S, Peterson J, Patel A, Pattar G, Evans DG, Vollmer PM, Wesley G. A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY(R) 0.025% for Ocular Redness in Adults. Ophthalmol Ther. 2025 Sep;14(9):2283-2299. doi: 10.1007/s40123-025-01194-z. Epub 2025 Jul 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 27, 2021 | Mar 15, 2024 |
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| Lumify® (brimonidine tartrate ophthalmic solution 0.025%) | Drug | 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. |
|
| Louisville |
| Kentucky |
| 40206 |
| United States |
| Bausch Site 01 | Andover | Massachusetts | 01810 | United States |
| Bausch Site 03 | Shelby | North Carolina | 28150 | United States |
| Bausch Site 02 | Memphis | Tennessee | 33119 | United States |
| Bausch Site 06 | Clinton | Utah | 84015 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Error | score on a scale | Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation. |
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|
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Through study completion, an average of 36 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 188 | 0 | 188 | 13 | 188 |
| EG001 | 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. | 0 | 190 | 1 | 190 | 18 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | Non-systematic Assessment |
| ||
| Covid 19 | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Instillation site pain | General disorders | Non-systematic Assessment |
|
Contact Sponsor directly for details
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Bausch and Lomb | 908-927-1162 | johnson.varughese@bausch.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2023 | Mar 15, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 30 minutes Post Instillation |
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| 60 minutes Post Instillation |
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| 90 minutes Post Instillation |
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| 120 minutes Post Instillation |
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| 180 minutes Post Instillation |
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| 240 minutes Post Instillation |
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