Open-angle GlaucomaPhase 4NCT00471068
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
A Phase 4 study testing Travatan and Cosopt in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Portugal.
Trial summary
To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in 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?
- Travatan and Cosopt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2007to Aug 2008
- Phase
- Phase 4
- 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
- Patient with open-angle glaucoma or ocular hypertension
Who cannot join
- By Age
Trial locations and contacts
1 site in 1 country.
About this study
To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Travatan, Cosopt, Placebo (Timolol Vehicle)
- 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.
TravatanDrug
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
CosoptDrug
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
Placebo (Timolol Vehicle)Drug
Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
| Study group | Role | What they receive |
|---|---|---|
| Travatan | Experimental | Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) Receives: Drug: Travatan; Drug: Placebo (Timolol Vehicle) |
| Cosopt | Active comparator | treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s) Receives: Drug: Cosopt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
IOP measured at week 6 minus IOP measured at baseline
Measured: At week 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
Why it stopped: Question raised by Ethics Committee
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Grau, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471068
- Sponsor's protocol ID
- EMD-05-03
- Status last verified
- Feb 2010
- First submitted
- 8 May 2007
- Last updated
- 11 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00471068
- Acronym / sponsor ID
- EMD-05-03
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Question raised by Ethics Committee
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- First posted
- 9 May 2007 (estimated)
- Results
- Posted 8 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travatan | Experimental | Drug: Travatan, Drug: Placebo (Timolol Vehicle)Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) |
| Cosopt | Active comparator | Drug: Cosopttreatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with open-angle glaucoma or ocular hypertension
Key exclusion criteria (1 listed)
- By Age
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 |
|---|---|---|
| TravatanTravatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) | Drug | Travatan |
| Cosopttreatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s) | Drug | Cosopt |
| Placebo (Timolol Vehicle)Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) | Drug | Travatan |
Primary outcome
Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
Time frame: At week 0 and week 6
IOP measured at week 6 minus IOP measured at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anna Grau study director
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 4 study testing Travatan and Cosopt in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Portugal.
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 1 inclusion and 1 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 11 Apr 2012. 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 Portugal. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 8 Jan 2010). 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?
Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment (time frame: At week 0 and week 6). 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 11 Apr 2012.