Glaucoma, Open-AnglePhase 3NCT00051142
A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
A Phase 3 study testing Travoprost and Latanoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic 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
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Travoprost and Latanoprost
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Jun 2004
- 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
Adult patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Travoprost, Latanoprost
- Keywords
- Glaucoma, POAG, OAG, OHT
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TravoprostDrug
LatanoprostDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2003 (estimated)
- Study startFeb 2001
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alcon Investigators, Principal investigator, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051142
- Sponsor's protocol ID
- C-01-36
- Status last verified
- Aug 2008
- First submitted
- 3 Jan 2003
- Last updated
- 5 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00051142
- Acronym / sponsor ID
- C-01-36
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Glaucoma, POAG, OAG, OHT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 7 Jan 2003 (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.
The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | Drug | – |
| Latanoprost | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2008.
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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.
Alcon Investigators principal investigator
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Travoprost and Latanoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Alcon Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 5 Aug 2008.