N/A N=2,580

A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Glaucoma, Open-Angle · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01646151 ↗

Enrolled (actual)

2,580

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Intraocular Pressure (IOP) at Baseline — 20.51; 20.65 Millimeters of Mercury (mmHg)

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Bimatoprost (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Allergan
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Intraocular Pressure (IOP) at Baseline	20.51; 20.65	—
PRIMARY IOP at Week 12	15.78; 15.87	—
SECONDARY Physician Evaluation of IOP Lowering in the Study Eye(s)	622; 1173; 467; 85; 119; 205	—
SECONDARY Patient Assessment of Tolerability on a 4-Point Scale	1127; 1070; 80; 70	—
SECONDARY Physician Assessment of Tolerability on a 4-Point Scale	1212; 1059; 74; 24	—
SECONDARY Physician Assessment of Patient Compliance Compared to Previous Therapy	875; 1151; 51; 36	—
SECONDARY Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment	6.6	—
SECONDARY Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops	85.8	—

Summary

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

Eligibility Criteria

Inclusion Criteria

Diagnosis of POAG or OHT
Previous use of IOP-lowering medication

Exclusion Criteria

None

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01646151). 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.