Trial · NCT01830140

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

NCT01830140, Phase 3, Completed, Allergan; results first posted 2015-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension. Trials, record NCT01830140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01830140

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
NCT number: NCT01830140
Status: Completed
Phases: Phase 3
Enrollment: 466 participants, actual
Lead sponsor: Allergan
Conditions: Glaucoma, Ocular Hypertension
Interventions: Bimatoprost 0.01%, Bimatoprost 0.03%
First posted: 2013-04-12
Last updated: 2015-05-06
Results first posted: 2015-05-06

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye	Baseline, 6 Weeks	Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye	Baseline, 6 Weeks	Intent-to-Treat: all randomized patients	Percentage of Patients	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye	Bimatoprost 0.01%		34.3		Percentage of Patients
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye	Bimatoprost 0.03%		39.1		Percentage of Patients

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bimatoprost 0.01%	233
Overall Study	STARTED	Bimatoprost 0.03%	233
Overall Study	COMPLETED	Bimatoprost 0.01%	226
Overall Study	COMPLETED	Bimatoprost 0.03%	229
Overall Study	NOT COMPLETED	Bimatoprost 0.01%	7
Overall Study	NOT COMPLETED	Bimatoprost 0.03%	4

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Eye Pruritus	Eye disorders	Bimatoprost 0.01%	7	233
other	Eye Pruritus	Eye disorders	Bimatoprost 0.03%	13	233
other	Conjunctival Hyperaemia	Eye disorders	Bimatoprost 0.01%	42	233
other	Conjunctival Hyperaemia	Eye disorders	Bimatoprost 0.03%	53	233
serious	Arthritis	Musculoskeletal and connective tissue disorders	Bimatoprost 0.01%	1	233
serious	Arthritis	Musculoskeletal and connective tissue disorders	Bimatoprost 0.03%	0	233
serious	Cerebrovascular Accident	Nervous system disorders	Bimatoprost 0.01%	1	233
serious	Cerebrovascular Accident	Nervous system disorders	Bimatoprost 0.03%	0	233
serious	Monoplegia	Nervous system disorders	Bimatoprost 0.01%	1	233
serious	Monoplegia	Nervous system disorders	Bimatoprost 0.03%	0	233

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bimatoprost 0.01%
Total, all-cause mortality	Bimatoprost 0.03%
Total, other adverse events	Bimatoprost 0.01%	49	233
Total, other adverse events	Bimatoprost 0.03%	66	233
Total, serious adverse events	Bimatoprost 0.01%	2	233
Total, serious adverse events	Bimatoprost 0.03%	2	233

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Bimatoprost 0.01% vs Bimatoprost 0.03%: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01830140

GET https://conductscience.org/api/trials/v1/NCT01830140/registered

API reference For AI assistants