18 and older, any sex, with Glaucoma, Open-Angle or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Intraocular Pressure (IOP) in the Study EyePrimary· Month 3
IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog \[PGA\] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combinatio
Group A (N=89)
Group
Value
95% CI
Bimatoprost 0.03%
16.5
± 3.4
Group B (N=33)
Group
Value
95% CI
Bimatoprost 0.03%
16.7
± 3.3
Group C (N=67)
Group
Value
95% CI
Bimatoprost 0.03%
15.7
± 2.6
Group D (N=18)
Group
Value
95% CI
Bimatoprost 0.03%
16.1
± 3.5
Group E (N=33)
Group
Value
95% CI
Bimatoprost 0.03%
17.2
± 4.4
Percentage of Patients With an Adverse Event of Conjunctival HyperemiaSecondary· 3 Months
Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Group
Value
95% CI
Bimatoprost 0.03%
76.0
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 18 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02061683.