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NCT02061683: LOTUS

A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

Completed Phase 4 Results posted Last updated 18 April 2019
What this trial tests

Phase 4 trial testing Bimatoprost 0.03% in Glaucoma, Open-Angle in 263 participants. Completed in 24 June 2011.

Timeline
19 April 2010
Primary endpoint
24 June 2011
24 June 2011

Quick facts

Lead sponsorAllergan
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment263
Start date19 April 2010
Primary completion24 June 2011
Estimated completion24 June 2011
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Allergan — full company profile →

Who can join

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 Eye Primary · 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)
GroupValue95% CI
Bimatoprost 0.03%16.5± 3.4
Group B (N=33)
GroupValue95% CI
Bimatoprost 0.03%16.7± 3.3
Group C (N=67)
GroupValue95% CI
Bimatoprost 0.03%15.7± 2.6
Group D (N=18)
GroupValue95% CI
Bimatoprost 0.03%16.1± 3.5
Group E (N=33)
GroupValue95% CI
Bimatoprost 0.03%17.2± 4.4
Percentage of Patients With an Adverse Event of Conjunctival Hyperemia Secondary · 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.

GroupValue95% 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.

Bimatoprost 0.03%
Serious: 0/250 (0%)
Deaths:
Other adverse events (3 terms — click to expand)

ReactionSystemBimatoprost 0.03%
Conjunctival HyperemiaEye disorders
Eyelash growthEye disorders
Skin pigmentationSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT02061683 adverse events section.

Sponsor's own description

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.

Verify or expand the search:

Other recruiting trials for Glaucoma, Open-Angle

Currently open trials in the same condition.

Other Allergan trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing