NCT02507687

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

Brief 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).

Interventional study

Status:
Completed
Conditions:
Glaucoma, Open-Angle
Ocular Hypertension
Enrollment:
240 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
192024-093
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye that
require IOP lowering treatment.

- In the investigator's opinion, patient's IOP is not adequately managed with topical
medication for reasons other than medication efficacy (eg, due to intolerance or
nonadherence).

- In the investigator's opinion, both eyes can be treated adequately with topical
prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if
medication was taken as directed, or with SLT monotherapy.

Exclusion Criteria:

- History of previous laser trabeculoplasty

- History or evidence of complicated cataract surgery: eg, surgery resulting in
complicated lens placement (such as anterior chamber intraocular lens implant [IOL],
sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior
capsular tear [with or without vitreous loss], substantial iris trauma, etc) or
history of phakic IOL insertion for refractive error correction

- Intraocular surgery (including cataract surgery) and/or any ocular laser surgery
within the 6 months prior to treatment

- Previous use of commercially available Bimatoprost SR; concurrent enrollment in
another Allergan Bimatoprost SR study; or previous enrollment in which an implant was
received.

All the cities where the clinical studies are located

Montreal - H1V 1G5

Quebec

More information about this study

clinicaltrials.gov