Glaucoma, Open-anglePhase 3NCT00311389
A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution and Latanoprost 0.005%/Timolol 0.005% ophthalmic solution in people with Glaucoma, Open-angle and Ocular Hypertension, run by Alcon Research at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy 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
- Glaucoma, Open-angle, Ocular Hypertension
- What is being tested?
- Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution and Latanoprost 0.005%/Timolol 0.005% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2003to Sep 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
Who may be able to join
- As specified in protocol
Who cannot join
- As specified in protocol
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Glaucoma, Open-angle, Ocular Hypertension
- Being tested
- Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution, Latanoprost 0.005%/Timolol 0.005% ophthalmic solution
- 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.
Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solutionDrug
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Latanoprost 0.005%/Timolol 0.005% ophthalmic solutionDrug
Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
| Study group | Role | What they receive |
|---|---|---|
| Travoprost/Timolol | Experimental | 1 drop in the affected eye(s) once daily in the morning for 12 months Receives: Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution |
| Latanoprost/Timolol | Active comparator | 1 drop in the affected eye(s) once daily in the morning for 12 months Receives: Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startJan 2003
- Primary completionSep 2004
- Study completionSep 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.
- 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
- 408 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
- NCT00311389
- Sponsor's protocol ID
- C-02-28
- Status last verified
- Feb 2012
- First submitted
- 4 Apr 2006
- Last updated
- 14 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00311389
- Acronym / sponsor ID
- C-02-28
- Conditions
- Glaucoma, Open-angle, Ocular Hypertension
- Keywords
- Glaucoma, POAG, OAG, OHT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 6 Apr 2006 (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 intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy 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 |
|---|---|---|
| Travoprost/Timolol | Experimental | Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution1 drop in the affected eye(s) once daily in the morning for 12 months |
| Latanoprost/Timolol | Active comparator | Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution1 drop in the affected eye(s) once daily in the morning for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- As specified in protocol
Key exclusion criteria (1 listed)
- As specified in protocol
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%/Timolol maleate 0.5% ophthalmic solutionInvestigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension | Drug | Travoprost/Timolol |
| Latanoprost 0.005%/Timolol 0.005% ophthalmic solutionCommercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension | Drug | Latanoprost/Timolol |
Primary outcome
Mean Intraocular Pressure (IOP)
Time frame: 12 months
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 14 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.
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 0.004%/Timolol maleate 0.5% ophthalmic solution and Latanoprost 0.005%/Timolol 0.005% ophthalmic solution in people with Glaucoma, Open-angle and Ocular Hypertension, run by Alcon Research at 1 site in Belgium.
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: finished, as of the sponsor's last update on 14 Feb 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 Belgium. 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.
What does the primary outcome measure?
Mean Intraocular Pressure (IOP) (time frame: 12 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 14 Feb 2012.