Trial · NCT01453855

Travoprost 3-Month Safety and Efficacy Study

NCT01453855, Phase 3, Completed, Alcon Research; results first posted 2013-10-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Travoprost 3-Month Safety and Efficacy Study. Trials, record NCT01453855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01453855

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Trial

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

Title: Travoprost 3-Month Safety and Efficacy Study
NCT number: NCT01453855
Status: Completed
Phases: Phase 3
Enrollment: 1,099 participants, actual
Lead sponsor: Alcon Research
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Interventions: Travoprost ophthalmic solution, 0.003%, Travoprost ophthalmic solution, 0.004%
First posted: 2011-10-18
Last updated: 2013-10-18
Other registries' IDs: eudract:2011-004587-29
Results first posted: 2013-10-18

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)	As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

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	Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)	The intent-to-treat (ITT) analysis set included all patients who received study drug and completed at least 1 scheduled on-therapy study visit. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.	millimeters mercury (mmHg)	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Category	Value	Spread	Units
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	Travoprost 0.003%	Week 2 at 8 AM	19.4	Standard Error 0.16	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	TRAVATAN	Week 2 at 8 AM	19.5	Standard Error 0.17	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	Travoprost 0.003%	Week 2 at 10 AM	18.6	Standard Error 0.16	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	TRAVATAN	Week 2 at 10 AM	18.6	Standard Error 0.16	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	Travoprost 0.003%	Week 2 at 4 PM	18.0	Standard Error 0.16	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	TRAVATAN	Week 2 at 4 PM	18.3	Standard Error 0.16	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	Travoprost 0.003%	Week 6 at 8 AM	19.3	Standard Error 0.16	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	TRAVATAN	Week 6 at 8 AM	19.3	Standard Error 0.17	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	Travoprost 0.003%	Week 6 at 10 AM	18.5	Standard Error 0.16	millimeters mercury (mmHg)
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	TRAVATAN	Week 6 at 10 AM	18.6	Standard Error 0.17	millimeters mercury (mmHg)

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Travoprost 0.003%	442
Overall Study	STARTED	TRAVATAN	422
Overall Study	COMPLETED	Travoprost 0.003%	432
Overall Study	COMPLETED	TRAVATAN	408
Overall Study	NOT COMPLETED	Travoprost 0.003%	10
Overall Study	NOT COMPLETED	TRAVATAN	14

Source ClinicalTrials.gov

Adverse events30

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	Ocular hyperaemia	Eye disorders	Travoprost 0.003%	31	442
other	Ocular hyperaemia	Eye disorders	TRAVATAN	34	421
other	Conjunctival hyperaemia	Eye disorders	Travoprost 0.003%	25	442
other	Conjunctival hyperaemia	Eye disorders	TRAVATAN	30	421
serious	Abdominal pain	Gastrointestinal disorders	Travoprost 0.003%	1	442
serious	Abdominal pain	Gastrointestinal disorders	TRAVATAN	0	421
serious	Chest Pain	General disorders	Travoprost 0.003%	2	442
serious	Chest Pain	General disorders	TRAVATAN	0	421
serious	Collapse of lung	Injury, poisoning and procedural complications	Travoprost 0.003%	1	442
serious	Collapse of lung	Injury, poisoning and procedural complications	TRAVATAN	0	421

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Travoprost 0.003%
Total, all-cause mortality	TRAVATAN
Total, other adverse events	Travoprost 0.003%	56	442
Total, other adverse events	TRAVATAN	64	421
Total, serious adverse events	Travoprost 0.003%	5	442
Total, serious adverse events	TRAVATAN	7	421

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
Travoprost 0.003% vs TRAVATAN: 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/NCT01453855

GET https://conductscience.org/api/trials/v1/NCT01453855/events?page=2

API reference For AI assistants