NCT02507687

Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension

A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).

Conditions

• Glaucoma, Open-Angle
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Bimatoprost SR	Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
DRUG	Sham Bimatoprost SR	Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
PROCEDURE	Selective Laser Trabeculoplasty	SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method.
PROCEDURE	Sham Selective Laser Trabeculoplasty	Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.

Timeline

• Start date: 2015-08-27
• Primary completion: 2021-11-24
• Completion: 2023-05-31
• First posted: 2015-07-24
• Last updated: 2024-05-10
• Results posted: 2024-05-10

Locations

95 sites across 12 countries: United States, Australia, Canada, Denmark, France, Germany, Israel, New Zealand, Philippines, Poland, Russia, United Kingdom

Regulatory

• FDA-regulated drug study