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Purpose

This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

• Diagnosis of either Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment

Exclusion Criteria

  • Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study
  • Previous administration with Bimatoprost SR in the study eye

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bimatoprost SR - Dose A 		Study Eye: Participants will receive 1 - 3 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
  • Drug: Bimatoprost (SR)
    Study Eye: Cycles 1 - 3 administrations through the Month 18 visit. Fellow Eye: Standard of care or Bimatoprost SR
Experimental
Bimatoprost SR - Dose B 		Study Eye: Participants received 1-3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
  • Drug: Bimatoprost (SR)
    Study Eye: Cycles 1 - 3 administrations through the Month 18 visit. Fellow Eye: Standard of care or Bimatoprost SR

Recruiting Locations

Tulane University Medical Center
New Orleans, Louisiana 70112
Contact:
Study Coordinator
504-558-5804

More Details

Status
Recruiting
Sponsor
Allergan

Study Contact

Clinical Trials Registry Team
1-877-277-8566
IR-CTRegistration@allergan.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.