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Brimonidine 0.025% preservative-free formulation · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
| 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. |
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 vas...
Brimonidine 0.025% preservative-free formulation is an investigational ophthalmic solution being developed by Bausch + Lomb Corporation for ocular redness. It is a small molecule alpha-2 adrenergic receptor agonist. The formulation omits preservatives, which is relevant for patients who use eye drops frequently or are sensitive to preservatives.
Brimonidine 0.025% preservative-free formulation is being developed to treat ocular redness in adults. The Phase 3 trial enrolled adults 18 years and older with ocular redness in the United States. It is investigational and has not been approved for this use.
Brimonidine 0.025% preservative-free formulation targets the alpha-2 adrenergic receptors ADRA2A, ADRA2B, and ADRA2C as an agonist. By activating these receptors, it acts as a vasoconstrictor to reduce conjunctival redness. The preservative-free formulation delivers the same active ingredient, brimonidine tartrate, without a preservative.
Bausch + Lomb Corporation (ticker BLCO) is developing brimonidine 0.025% preservative-free formulation. The company sponsored the Phase 3 trial evaluating the product in adults with ocular redness.
Brimonidine 0.025% preservative-free formulation is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. It is investigational and has not been approved by the FDA for ocular redness.
Brimonidine 0.025% preservative-free formulation was studied in the Phase 3 trial NCT05360784, titled Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness. The trial was completed, enrolled 380 participants, was randomized, double-blind, and active-controlled, and was conducted in the United States.