Open-Angle GlaucomaPhase 3NCT00672997
A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution and Travoprost 0.004%/Timolol 0.5% ophthalmic solution in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution and Travoprost 0.004%/Timolol 0.5% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Dec 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open-angle glaucoma or confirmed ocular hypertension.
- Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 \& 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 \& 2.
- Sign an informed consent form.
- Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
- History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
- History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
- Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
- Severe central visual field loss in either eye.
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- Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
- History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
- History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Six-Week, Multi-Center, Double-Masked, Safety and Efficacy Study of Travoprost 0.004%/Timolol 0.5% BAC-free Compared to Travoprost 0.004%/Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution, Travoprost 0.004%/Timolol 0.5% ophthalmic solution
- Keywords
- Glaucoma, 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% BAC-free ophthalmic solutionDrug
Travoprost 0.004%/Timolol 0.5% ophthalmic solutionDrug
Also called DuoTrav®
| Study group | Role | What they receive |
|---|---|---|
| Travoprost/Timolol BAC-free | Experimental | Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks Receives: Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution |
| Travoprost/Timolol | Active comparator | Travoprost 0.004%/Timolol 0.5% ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks Receives: Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP) combined across all visits and timepoints
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).
Measured: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)
Secondary outcomes (1)
Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).
Measured: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Smith, B.S., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672997
- Sponsor's protocol ID
- C-07-64
- Status last verified
- Jul 2014
- First submitted
- 2 May 2008
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-Week, Multi-Center, Double-Masked, Safety and Efficacy Study of Travoprost 0.004%/Timolol 0.5% BAC-free Compared to Travoprost 0.004%/Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00672997
- Acronym / sponsor ID
- C-07-64
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 May 2008 (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 demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travoprost/Timolol BAC-free | Experimental | Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solutionTravoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks |
| Travoprost/Timolol | Active comparator | Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solutionTravoprost 0.004%/Timolol 0.5% ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Open-angle glaucoma or confirmed ocular hypertension.
- Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 \& 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 \& 2.
- Sign an informed consent form.
- Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (10 listed)
- Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
- History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
- History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
- Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
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% BAC-free ophthalmic solution | Drug | Travoprost/Timolol BAC-free |
| Travoprost 0.004%/Timolol 0.5% ophthalmic solutionAlso: DuoTrav® | Drug | Travoprost/Timolol |
Primary outcome
Mean Intraocular Pressure (IOP) combined across all visits and timepoints
Time frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).
1 secondary outcome
Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit
Time frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)
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 16 Jul 2014.
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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.
Pamela Smith, B.S. study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution and Travoprost 0.004%/Timolol 0.5% ophthalmic solution 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 5 inclusion and 10 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 16 Jul 2014. 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) combined across all visits and timepoints (time frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)). 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 16 Jul 2014.