Trial · NCT01298700

Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT01298700, Phase 4, Completed, Allergan; results first posted 2018-09-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension. Trials, record NCT01298700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01298700

On this page

Trial

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

Title: Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
NCT number: NCT01298700
Status: Completed
Phases: Phase 4
Enrollment: 806 participants, actual
Lead sponsor: Allergan
Conditions: Glaucoma, Ocular Hypertension
Interventions: bimatoprost 0.01% ophthalmic solution, bimatoprost 0.03% ophthalmic solution
First posted: 2011-02-18
Last updated: 2018-09-17
Other registries' IDs: eudract:2010-023917-68
Results first posted: 2018-09-17

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events	24 Months	An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.
Secondary	Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"	24 Months	An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events	24 Months	Safety population included all participants who received at least one dose of study drug.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia	24 Months	Safety population included all participants who received at least one dose of study drug.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events	Bimatoprost 0.01% Ophthalmic Solution	33.3	percentage of participants
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events	Bimatoprost 0.03% Ophthalmic Solution	37.7	percentage of participants
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia	Bimatoprost 0.01% Ophthalmic Solution	26.0	percentage of participants
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia	Bimatoprost 0.03% Ophthalmic Solution	29.6	percentage of participants

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Bimatoprost 0.01% Ophthalmic Solution	403
Overall Study	STARTED	Bimatoprost 0.03% Ophthalmic Solution	403
Overall Study	Safety Population: Received Study Drug	Bimatoprost 0.01% Ophthalmic Solution	400
Overall Study	Safety Population: Received Study Drug	Bimatoprost 0.03% Ophthalmic Solution	398
Overall Study	COMPLETED	Bimatoprost 0.01% Ophthalmic Solution	302
Overall Study	COMPLETED	Bimatoprost 0.03% Ophthalmic Solution	303
Overall Study	NOT COMPLETED	Bimatoprost 0.01% Ophthalmic Solution	101
Overall Study	NOT COMPLETED	Bimatoprost 0.03% Ophthalmic Solution	100

Source ClinicalTrials.gov

Adverse events214

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	Blepharitis	Eye disorders	Bimatoprost 0.01% Ophthalmic Solution	14	400
other	Blepharitis	Eye disorders	Bimatoprost 0.03% Ophthalmic Solution	23	398
other	Cataract	Eye disorders	Bimatoprost 0.01% Ophthalmic Solution	20	400
other	Cataract	Eye disorders	Bimatoprost 0.03% Ophthalmic Solution	24	398
other	Conjunctival hyperaemia	Eye disorders	Bimatoprost 0.01% Ophthalmic Solution	80	400
other	Conjunctival hyperaemia	Eye disorders	Bimatoprost 0.03% Ophthalmic Solution	90	398
other	Dry eye	Eye disorders	Bimatoprost 0.01% Ophthalmic Solution	36	400
other	Dry eye	Eye disorders	Bimatoprost 0.03% Ophthalmic Solution	42	398
other	Eye pain	Eye disorders	Bimatoprost 0.01% Ophthalmic Solution	21	400
other	Eye pain	Eye disorders	Bimatoprost 0.03% Ophthalmic Solution	20	398

1 to 10 of 214Source ClinicalTrials.gov

See all 214 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% Ophthalmic Solution
Total, all-cause mortality	Bimatoprost 0.03% Ophthalmic Solution
Total, other adverse events	Bimatoprost 0.01% Ophthalmic Solution	167	400
Total, other adverse events	Bimatoprost 0.03% Ophthalmic Solution	186	398
Total, serious adverse events	Bimatoprost 0.01% Ophthalmic Solution	45	400
Total, serious adverse events	Bimatoprost 0.03% Ophthalmic Solution	40	398

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% Ophthalmic Solution vs Bimatoprost 0.03% Ophthalmic Solution: 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/NCT01298700

GET https://conductscience.org/api/trials/v1/NCT01298700/events?page=2

API reference For AI assistants