Open-angle GlaucomaNCT01485822
A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution
An observational study of Open-angle Glaucoma, run by Alcon Research.
Trial summary
The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- Trabecular Meshwork Tissue Collection and Travoprost 0.004% ophthalmic solution
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Feb 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were identified and enrolled from 9 study centers in the US and 1 in Spain.
Who may be able to join
- Diagnosis of open-angle glaucoma without pseudoexfoliation or pigment dispersion component;
- Either two or more years of dosing with Travatan, or no prior exposure (less than 1 month) to a topical ocular prostaglandin;
- Requires a trabeculectomy;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Pseudoexfoliation or pigment dispersion;
- History of chronic or recurrent severe inflammatory eye disease;
- History of or current ocular infection or ocular inflammation within the past 3 months in either eye;
- Greater than one month but less than two years of exposure to TRAVATAN;
- Pregnant, breast-feeding, not using highly effective birth control;
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA).
- Conditions
- Open-angle Glaucoma
- Being tested
- Trabecular Meshwork Tissue Collection, Travoprost 0.004% ophthalmic solution
- Keywords
- Glaucoma, Travatan, Trabeculectomy
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabecular Meshwork Tissue CollectionProcedure or surgery
A minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy.
Travoprost 0.004% ophthalmic solutionDrug
Also called TRAVATAN Z, TRAVATAN
| Study group | Role | What they receive |
|---|---|---|
| TRAVATAN | As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years Receives: Procedure: Trabecular Meshwork Tissue Collection; Drug: Travoprost 0.004% ophthalmic solution | |
| Treatment Naive | No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue Receives: Procedure: Trabecular Meshwork Tissue Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanin Granule Count
A trabecular meshwork tissue sample was collected by the investigator. The number of pigment granules was counted for three separate microscopic fields of view. Mean melanin granule count was calculated.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startJul 2004
- Primary completionFeb 2012
- Study completionFeb 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.
- 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
- 88 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
- NCT01485822
- Sponsor's protocol ID
- C-01-78
- Status last verified
- May 2013
- First submitted
- 1 Dec 2011
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution
- ClinicalTrials.gov ID
- NCT01485822
- Acronym / sponsor ID
- C-01-78
- Conditions
- Open-angle Glaucoma
- Keywords
- Glaucoma, Travatan, Trabeculectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study objectives met
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Dec 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.
The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRAVATAN | – | Procedure: Trabecular Meshwork Tissue Collection, Drug: Travoprost 0.004% ophthalmic solutionAs prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years |
| Treatment Naive | – | Procedure: Trabecular Meshwork Tissue CollectionNo prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were identified and enrolled from 9 study centers in the US and 1 in Spain.
Key inclusion criteria (4 listed)
- Diagnosis of open-angle glaucoma without pseudoexfoliation or pigment dispersion component;
- Either two or more years of dosing with Travatan, or no prior exposure (less than 1 month) to a topical ocular prostaglandin;
- Requires a trabeculectomy;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Pseudoexfoliation or pigment dispersion;
- History of chronic or recurrent severe inflammatory eye disease;
- History of or current ocular infection or ocular inflammation within the past 3 months in either eye;
- Greater than one month but less than two years of exposure to TRAVATAN;
- Pregnant, breast-feeding, not using highly effective birth control;
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 |
|---|---|---|
| Trabecular Meshwork Tissue CollectionA minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy. | Procedure or surgery | TRAVATAN, Treatment Naive |
| Travoprost 0.004% ophthalmic solutionAlso: TRAVATAN Z, TRAVATAN | Drug | TRAVATAN |
Primary outcome
Melanin Granule Count
Time frame: Day 1
A trabecular meshwork tissue sample was collected by the investigator. The number of pigment granules was counted for three separate microscopic fields of view. Mean melanin granule count was calculated.
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 14 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, 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 6 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 14 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?
Melanin Granule Count (time frame: Day 1). 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 14 May 2013.