Open-angle GlaucomaPhase 3NCT00293787
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution (XALATAN) and Timolol Maleate Ophthalmic Solution 0.5% in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating 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?
- Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution (XALATAN) and Timolol Maleate Ophthalmic Solution 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Aug 2005
- 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
- 18 years or older.
- Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
- Mean IOP in each eye less than 18 mmHg at the screening visit.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Pregnant.
- History of chronic or recurrent severe inflammatory eye disease.
- Ocular trauma within the past six months in either eye.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution, Timolol Vehicle, Latanoprost 0.005% Ophthalmic Solution (XALATAN), Timolol Maleate Ophthalmic Solution 0.5%
- Keywords
- Open-angle, glaucoma, ocular, hypertension
- 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% / Timolol 0.5% Ophthalmic SolutionDrug
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Timolol VehicleOther
Placebo
Latanoprost 0.005% Ophthalmic Solution (XALATAN)Drug
Also called XALATAN
Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
Timolol Maleate Ophthalmic Solution 0.5%Drug
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
| Study group | Role | What they receive |
|---|---|---|
| Travoprost 0.004%/Timolol 0.5% | Experimental | Travoprost 0.004%/Timolol 0.5% in both eyes each morning at 8 a.m. and Timolol vehicle in both eyes each evening at 8 p.m. for 3 months Receives: Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution; Other: Timolol Vehicle |
| Xalatan + Timolol 0.5% | Active comparator | Timolol 0.5% in both eyes each morning at 8 a.m. and Xalatan in both eyes each evening at 8 p.m. for 3 months Receives: Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN); Drug: Timolol Maleate Ophthalmic Solution 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intraocular pressure (IOP) change at 3 months from baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startJun 2004
- Primary completionAug 2005
- Study completionAug 2005
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 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
- NCT00293787
- Sponsor's protocol ID
- C-04-03
- Status last verified
- Feb 2012
- First submitted
- 17 Feb 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 Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00293787
- Acronym / sponsor ID
- C-04-03
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- Open-angle, glaucoma, ocular, hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 20 Feb 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 the study is to evaluate the safety and effectiveness of an investigational therapy for treating 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 0.004%/Timolol 0.5% | Experimental | Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution, Other: Timolol VehicleTravoprost 0.004%/Timolol 0.5% in both eyes each morning at 8 a.m. and Timolol vehicle in both eyes each evening at 8 p.m. for 3 months |
| Xalatan + Timolol 0.5% | Active comparator | Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN), Drug: Timolol Maleate Ophthalmic Solution 0.5%Timolol 0.5% in both eyes each morning at 8 a.m. and Xalatan in both eyes each evening at 8 p.m. for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older.
- Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
- Mean IOP in each eye less than 18 mmHg at the screening visit.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Pregnant.
- History of chronic or recurrent severe inflammatory eye disease.
- Ocular trauma within the past six months in either 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% / Timolol 0.5% Ophthalmic SolutionInvestigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension | Drug | Travoprost 0.004%/Timolol 0.5% |
| Timolol VehiclePlacebo | Other | Travoprost 0.004%/Timolol 0.5% |
| Latanoprost 0.005% Ophthalmic Solution (XALATAN)Also: XALATANCommercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension | Drug | Xalatan + Timolol 0.5% |
| Timolol Maleate Ophthalmic Solution 0.5%Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension | Drug | Xalatan + Timolol 0.5% |
Primary outcome
Mean intraocular pressure (IOP) change at 3 months from baseline
Time frame: 3 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution (XALATAN) and Timolol Maleate Ophthalmic Solution 0.5% in people with 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 4 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.
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) change at 3 months from baseline (time frame: 3 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.