GlaucomaPhase 4NCT00763061
Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
A Phase 4 study testing Travoprost 0.004% Ophthalmic Solution (Travatan) and Timolol 0.5% Ophthalmic Solution (Timoptic) in people with Glaucoma, run by Alcon Research at 1 site in United States.
Trial summary
To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Travoprost 0.004% Ophthalmic Solution (Travatan) and Timolol 0.5% Ophthalmic Solution (Timoptic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Apr 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
- ≥18 years;
- IOP=16-30mmHg
- OH or OAG with visual filed abnormality:
- ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
- Glaucoma Hemifield Test outside normal limits,
- Corrected Pattern Standard Deviation with p <5%
Who cannot join
- Previous damage of anterior chamber angle;
- ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
- contact lens wearer;
- severe central field loss;
- uncontrolled cardiovascular, hepatic or renal disease;
- any medication within past 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
Read the detailed description
To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
- Conditions
- Glaucoma
- Being tested
- Travoprost 0.004% Ophthalmic Solution (Travatan), Timolol 0.5% Ophthalmic Solution (Timoptic)
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost 0.004% Ophthalmic Solution (Travatan)Drug
Travoprost at 9 AM + Placebo \& 9 PM
Timolol 0.5% Ophthalmic Solution (Timoptic)Drug
Timolol in each eye, twice daily at 9 AM \& 9 PM
| Study group | Role | What they receive |
|---|---|---|
| Travoprost 0.004% | Experimental | Travoprost 0.004% Receives: Drug: Travoprost 0.004% Ophthalmic Solution (Travatan) |
| Timolol 0.5% | Active comparator | Timolol 0.5% Receives: Drug: Timolol 0.5% Ophthalmic Solution (Timoptic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP) at 9 AM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Measured: At Week 12 - At the 9 AM time point for the patient's worse eye.
Week 12 - Mean IOP At 4 PM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Measured: At the 4 PM time point for the patient's worse eye.
Secondary outcomes (2)
Mean IOP Change From Baseline at 9 AM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Measured: Baseline to Week 12 - at 9 AM
Mean IOP Change at 4 PM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Measured: Baseline to Week 12 - at 4 PM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startMay 2006
- Primary completionApr 2008
- Study completionApr 2008
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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763061
- Sponsor's protocol ID
- MS-06-02
- Status last verified
- Feb 2010
- First submitted
- 26 Sep 2008
- Last updated
- 2 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00763061
- Acronym / sponsor ID
- MS-06-02
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 26 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 evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
Detailed description
To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
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% | Experimental | Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)Travoprost 0.004% |
| Timolol 0.5% | Active comparator | Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)Timolol 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years;
- IOP=16-30mmHg
- OH or OAG with visual filed abnormality:
Key exclusion criteria (6 listed)
- Previous damage of anterior chamber angle;
- ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
- contact lens wearer;
- severe central field loss;
- uncontrolled cardiovascular, hepatic or renal disease;
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 Solution (Travatan)Travoprost at 9 AM + Placebo \& 9 PM | Drug | Travoprost 0.004% |
| Timolol 0.5% Ophthalmic Solution (Timoptic)Timolol in each eye, twice daily at 9 AM \& 9 PM | Drug | Timolol 0.5% |
Primary outcome
Mean Intraocular Pressure (IOP) at 9 AM
Time frame: At Week 12 - At the 9 AM time point for the patient's worse eye.
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Week 12 - Mean IOP At 4 PM
Time frame: At the 4 PM time point for the patient's worse eye.
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
2 secondary outcomes
Mean IOP Change From Baseline at 9 AM
Time frame: Baseline to Week 12 - at 9 AM
Mean IOP Change at 4 PM
Time frame: Baseline to Week 12 - at 4 PM
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
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 4 study testing Travoprost 0.004% Ophthalmic Solution (Travatan) and Timolol 0.5% Ophthalmic Solution (Timoptic) in people with Glaucoma, run by Alcon Research at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 2 Mar 2010. 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 United States. 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 26 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?
Mean Intraocular Pressure (IOP) at 9 AM (time frame: At Week 12 - At the 9 AM time point for the patient's worse eye.). The study lists 2 primary outcomes in all. 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 2 Mar 2010.