This study is investigating the safety and effectiveness of two different dose strengths (10 μg or 15 μg) of the Bimatoprost Sustained Release (SR) compared to treatment with Timolol 0.5% eye drops in lowering eye pressure in patients with open-angle glaucoma or high eye-pressure. Timolol 0.5% is an approved drug for lowering eye pressure.
The Bimatoprost SR is an implant that is very small, is biodegradable (dissolves naturally in the body), and contains the bimatoprost drug. Bimatoprost SR is placed inside the eye in the intracameral area (between the cornea [the clear part of the eye] and the iris [the colored part of the eye]). After Bimatoprost SR is placed in the eye, the drug is slowly released for about 3 to 4 months. The Bimatoprost SR study drug is the same active ingredient as the commercially approved bimatoprost eye drops (LUMIGAN®) for lowering the pressure inside the eye. LUMIGAN® eye drops have been shown to be safe and effective for patients with glaucoma or high eye pressure.
We hope to show in this study that the Bimatoprost SR implant can control the eye pressures for a longer period of time without the need for daily use and the cost of multiple eye drops.
- 18 Years and older
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
- Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
- Anticipated need for laser eye surgery in either eye within the first 52 weeks of the study duration
- History of glaucoma surgery
Enrollment in the Study
Meliza Unson, CRC: 212-979-4672
Katy Tai, CRC: 212-979-4251, firstname.lastname@example.org