Open Angle GlaucomaPhase 3NCT01452009
Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%
A Phase 3 study testing Travoprost Ophthalmic Solution, 0.004% (New Formulation) and TRAVATAN® in people with Open Angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004% 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, 0.004% (New Formulation) and TRAVATAN®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients 18 years of age or older
- Either gender
- Any race/ethnicity
- Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension
Who cannot join
- Patients with any form of glaucoma other than open-angle glaucoma.
- Patients with a central cornea thickness greater than 620 μm
- Patients with Shaffer angle Grade < 2
- Patients with a cup/disc ratio greater than 0.80
- Patients with severe central visual field loss
- Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
Show all 9Show fewer
- Chronic, recurrent or severe inflammatory eye disease
- Clinically significant or progressive retinal disease
- Other ocular pathology
About this study
Official title: Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%
A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost Ophthalmic Solution, 0.004% (New Formulation), TRAVATAN®
- 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, 0.004% (New Formulation)Drug
Travoprost Ophthalmic Solution, 0.004% given one drop once daily
TRAVATAN®Drug
TRAVATAN® administered one drop once daily
| Study group | Role | What they receive |
|---|---|---|
| Travoprost Ophthalmic Solution, 0.004% (New Formulation) | Experimental | Not described Receives: Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation) |
| TRAVATAN® | Active comparator | TRAVATAN® administered one drop once daily Receives: Drug: TRAVATAN® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: mean IOP Efficacy as measured by mean IOP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Management Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452009
- Sponsor's protocol ID
- C-10-151
- Status last verified
- Feb 2012
- First submitted
- 12 Oct 2011
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%
- ClinicalTrials.gov ID
- NCT01452009
- Acronym / sponsor ID
- C-10-151
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- open angle glaucoma, ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travoprost Ophthalmic Solution, 0.004% (New Formulation) | Experimental | Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation) |
| TRAVATAN® | Active comparator | Drug: TRAVATAN®TRAVATAN® administered one drop once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years of age or older
- Either gender
- Any race/ethnicity
- Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension
Key exclusion criteria (9 listed)
- Patients with any form of glaucoma other than open-angle glaucoma.
- Patients with a central cornea thickness greater than 620 μm
- Patients with Shaffer angle Grade < 2
- Patients with a cup/disc ratio greater than 0.80
- Patients with severe central visual field loss
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, 0.004% (New Formulation)Travoprost Ophthalmic Solution, 0.004% given one drop once daily | Drug | Travoprost Ophthalmic Solution, 0.004% (New Formulation) |
| TRAVATAN®TRAVATAN® administered one drop once daily | Drug | TRAVATAN® |
Primary outcome
Efficacy: mean IOP Efficacy as measured by mean IOP
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Travoprost Ophthalmic Solution, 0.004% (New Formulation) and TRAVATAN® 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 9 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: withdrawn, as of the sponsor's last update on 10 Feb 2012. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy: mean IOP Efficacy as measured by mean IOP (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2012.