N/A Completed N=1,553

A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting

Glaucoma, Primary Open Angle · Hypertension

Source: ClinicalTrials.gov NCT01999348 ↗

Enrolled (actual)

1,553

Serious AEs

0.1%

Results posted

Dec 2015

Primary outcomePrimary: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye — 22.18; 16.11 mmHg

Summary

The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Intraocular Pressure (IOP) in the Study Eye	22.18; 16.11	—
SECONDARY Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale	497; 729; 98; 67	—
SECONDARY Patient Assessment of Tolerability on a 4-Point Scale	788; 461; 45; 50; 47	—
SECONDARY Physician Assessment of Tolerability on a 4-Point Scale	809; 474; 40; 28; 40	—
SECONDARY Percentage of Patients Who Discontinued Treatment	6.47	—
SECONDARY Percentage of Patients Prescribed by the Physician to Continue Treatment	89.14	—
SECONDARY Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale	727; 542; 34; 49	—

Eligibility Criteria

Inclusion Criteria

Diagnosed with primary open-angle glaucoma or ocular hypertension
Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

Exclusion Criteria

None

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01999348). 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. Informational only — not medical advice.