Open-Angle GlaucomaPhase 3NCT01453855

Travoprost 3-Month Safety and Efficacy Study

A Phase 3 study testing Travoprost ophthalmic solution, 0.003% and Travoprost ophthalmic solution, 0.004% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: Travoprost ophthalmic solution, 0.003% and Travoprost ophthalmic solution, 0.004%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,099 participants
Where: No sites listed yet
Study dates: Nov 2011to Aug 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
Qualifying intraocular pressure at both eligibility visits.
Understand and sign an informed consent form.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
Any abnormality preventing reliable applanation tonometry.
Hypersensitivity to prostaglandin analogs or to any component of the study medications.
Therapy with another investigational agent within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients With Open-Angle Glaucoma or Ocular Hypertension

Read the detailed description

This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Travoprost ophthalmic solution, 0.003%, Travoprost ophthalmic solution, 0.004%
Keywords: Open-Angle Glaucoma, Ocular Hypertension
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Travoprost ophthalmic solution, 0.003%Drug
Travoprost ophthalmic solution, 0.004%Drug
Also called TRAVATAN®

Study groups in NCT01453855
Study group	Role	What they receive
Travoprost 0.003%	Experimental	Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months Receives: Drug: Travoprost ophthalmic solution, 0.003%
TRAVATAN	Active comparator	Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months Receives: Drug: Travoprost ophthalmic solution, 0.004%

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 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).
Measured: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Aug 2012

First posted18 Oct 2011 (estimated)
Study startNov 2011
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,099 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01453855
Sponsor's protocol ID: C-11-034
Other IDs: 2011-004587-29
Status last verified: Aug 2013
First submitted: 13 Oct 2011
Last updated: 18 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients With Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01453855
Acronym / sponsor ID: C-11-034
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Keywords: Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,099 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 18 Oct 2011 (estimated)
Results: Posted 18 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Travoprost 0.003%	Experimental	Drug: Travoprost ophthalmic solution, 0.003%Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
TRAVATAN	Active comparator	Drug: Travoprost ophthalmic solution, 0.004%Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
Qualifying intraocular pressure at both eligibility visits.
Understand and sign an informed consent form.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (8 listed)

Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
Any abnormality preventing reliable applanation tonometry.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Travoprost ophthalmic solution, 0.003%	Drug	Travoprost 0.003%
Travoprost ophthalmic solution, 0.004%Also: TRAVATAN®	Drug	TRAVATAN

Primary outcome

Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)
Time frame: 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).

Results and safety

Results posted to the registry on 18 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Travoprost 0.003%	442	432
TRAVATAN	422	408

Primary outcome: Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)

Time frame: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM). Least squares mean (Standard Error). Unit: millimeters mercury (mmHg)

Measure	Travoprost 0.003% n = 442	TRAVATAN n = 416
Week 2 at 8 AM	19.4 (0.16)	19.5 (0.17)
Week 2 at 10 AM	18.6 (0.16)	18.6 (0.16)
Week 2 at 4 PM	18.0 (0.16)	18.3 (0.16)
Week 6 at 8 AM	19.3 (0.16)	19.3 (0.17)
Week 6 at 10 AM	18.5 (0.16)	18.6 (0.17)
Week 6 at 4 PM	18.0 (0.16)	18.1 (0.17)
Month 3 at 8 AM	19.2 (0.17)	19.3 (0.18)
Month 3 at 10 AM	18.3 (0.17)	18.6 (0.18)

Population analysed: 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.

Adverse events

Time frame: Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Travoprost 0.003%	5 of 442 (1.1%)	56 of 442 (12.7%)	Not reported
TRAVATAN	7 of 421 (1.7%)	64 of 421 (15.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open-Angle Glaucoma

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Theresa A Landry, PhD study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Travoprost ophthalmic solution, 0.003% and Travoprost ophthalmic solution, 0.004% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) (time frame: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01453855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2013.