Phase 3 N=466 Randomized Double-blind Treatment

A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

Glaucoma · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01830140 ↗

Enrolled (actual)

466

Serious AEs

0.9%

Results posted

May 2015

Primary outcome: Primary: Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye — 34.3; 39.1 Percentage of Patients

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bimatoprost 0.01% (Drug); Bimatoprost 0.03% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye	34.3; 39.1	—

Summary

This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).

Eligibility Criteria

Inclusion Criteria

Diagnosis of glaucoma or ocular hypertension

Exclusion Criteria

Active ocular disease other than glaucoma or ocular hypertension
Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01830140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.