Open-Angle GlaucomaNCT00047554
Study of TRAVATAN in Subjects With Iris Pigmentation Changes
An observational study of Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Travoprost, 0.004% ophthalmic solution
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jun 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients were identified and enrolled from 23 investigational centers in the US.
Who may be able to join
- Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension;
- Has experienced an iris pigmentation change while dosing with TRAVATAN;
- Currently dosing with TRAVATAN;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension;
- Not currently using TRAVATAN;
- Females of childbearing potential if pregnant, breast-feeding, or not using highly effective birth control measures;
- History of any severe ocular pathology (including severe dry eye);
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Five-Year, Multicenter, Commercial Label Safety Study of TRAVATAN® 0.004% in Patients With TRAVATAN-Induced Iris Pigmentation Changes
The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost, 0.004% ophthalmic solution
- Keywords
- open-angle, glaucoma, ocular, hypertension, primary open-angle glaucoma, iris, pigmentation
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost, 0.004% ophthalmic solutionDrug
Also called TRAVATAN®
| Study group | Role | What they receive |
|---|---|---|
| TRAVATAN | Travoprost, 0.004% ophthalmic solution, 1 drop to the study eye once daily in the evening for up to 5 years Receives: Drug: Travoprost, 0.004% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Iris Pigmentation from Baseline for Study Eye by Visit
As assessed by ocular photography
Measured: Baseline, Up to Year 5
Secondary outcomes (1)
Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit
As assessed by ocular photography
Measured: Baseline, Up to Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2002 (estimated)
- Study startMay 2003
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Study objectives met
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Landry, PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047554
- Sponsor's protocol ID
- C-01-79
- Status last verified
- May 2013
- First submitted
- 8 Oct 2002
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Five-Year, Multicenter, Commercial Label Safety Study of TRAVATAN® 0.004% in Patients With TRAVATAN-Induced Iris Pigmentation Changes
- ClinicalTrials.gov ID
- NCT00047554
- Acronym / sponsor ID
- C-01-79
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- open-angle, glaucoma, ocular, hypertension, primary open-angle glaucoma, iris, pigmentation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study objectives met
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Oct 2002 (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 was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRAVATAN | – | Drug: Travoprost, 0.004% ophthalmic solutionTravoprost, 0.004% ophthalmic solution, 1 drop to the study eye once daily in the evening for up to 5 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were identified and enrolled from 23 investigational centers in the US.
Key inclusion criteria (4 listed)
- Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension;
- Has experienced an iris pigmentation change while dosing with TRAVATAN;
- Currently dosing with TRAVATAN;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension;
- Not currently using TRAVATAN;
- Females of childbearing potential if pregnant, breast-feeding, or not using highly effective birth control measures;
- History of any severe ocular pathology (including severe dry eye);
- Other protocol-defined exclusion criteria may apply.
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, 0.004% ophthalmic solutionAlso: TRAVATAN® | Drug | TRAVATAN |
Primary outcome
Change in Iris Pigmentation from Baseline for Study Eye by Visit
Time frame: Baseline, Up to Year 5
As assessed by ocular photography
1 secondary outcome
Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit
Time frame: Baseline, Up to Year 5
Results and safety
The study was stopped early (reason given: Study objectives met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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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.
Theresa Landry, PhD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 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: stopped early, as of the sponsor's last update on 15 May 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.
Are results available for this study?
The study was stopped early (reason given: Study objectives met). Results are not available in the source record.
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?
Change in Iris Pigmentation from Baseline for Study Eye by Visit (time frame: Baseline, Up to Year 5). 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 15 May 2013.