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Also known as Test - Bimatoprost 0.01% Ophthalmic Solution, Test- Bimatoprost 0.01%
Bimatoprost ophthalmic solution · 1 trial · 2 indications
Change in mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hour, 04.00 hours, and 08.00 hours at Day 14 (Week 2) and Day 42 (Week 6) visits
| Arm | Type | Description |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | EXPERIMENTAL | Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc. |
| LUMIGAN® 0.01% Ophthalmic Solution | ACTIVE_COMPARATOR | Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc. |
| Name | Type | Description |
|---|---|---|
| Test - Bimatoprost 0.01% Ophthalmic Solution | DRUG | Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days. |
| Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) | DRUG | Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days. |
Inclusion Criteria: * Subjects willing and able to provide voluntary informed consent and to follow protocol requirements. * Male or females aged ≥18 years. * Subjects having body mass index (BMI) ≥18.50 kg/m2. * Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. * Subje...
Bimatoprost ophthalmic solution is used to treat chronic open-angle glaucoma and ocular hypertension. It is being developed as a 0.01% ophthalmic solution for these eye conditions, which involve elevated pressure inside the eye. The active development program focuses on lowering intraocular pressure in adults with these diagnoses.
Bimatoprost ophthalmic solution targets PTGFR, the prostaglandin F receptor. It acts as an agonist at this receptor, meaning it activates the receptor rather than blocking it. This receptor activity is the basis for its development in glaucoma and ocular hypertension.
Amneal Pharmaceuticals, Inc. is developing bimatoprost ophthalmic solution. The company trades under the ticker AMRX. Amneal is the sponsor behind the clinical program evaluating the 0.01% ophthalmic solution in glaucoma and ocular hypertension.
Bimatoprost ophthalmic solution is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 program is ongoing, with the single registered trial currently recruiting participants.
Bimatoprost ophthalmic solution is being studied in the Phase 3 trial NCT05401357, titled a bioequivalence study with clinical endpoint comparing bimatoprost ophthalmic solution 0.01% and LUMIGAN in chronic open-angle glaucoma or ocular hypertension in both eyes. The trial is recruiting in the United States and plans to enroll 168 participants.
Yes, bimatoprost ophthalmic solution is also known as bimatoprost 0.01% ophthalmic solution. These names refer to the same Amneal Pharmaceuticals product candidate being evaluated in Phase 3 for open-angle glaucoma and ocular hypertension. The 0.01% refers to the concentration of the ophthalmic solution.