Angle-closure GlaucomaPhase 4NCT00762645
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)
A Phase 4 study testing Travoprost 0.004% (Travatan) and Pilocarpine 1% in people with Angle-closure Glaucoma, run by Alcon Research.
Trial summary
The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angle-closure Glaucoma
- What is being tested?
- Travoprost 0.004% (Travatan) and Pilocarpine 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to May 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
- Age ≥ 18 years
- Chronic Angle Closure Glaucoma (CACG)
- 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
- Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
- Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
- Peripheral anterior synechiae (PAS)
Who cannot join
- Traumatic damage of the anterior chamber angle
- History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
- Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
- Visual Acuity ≥ 1.0
- Contact lenses wearer
About this study
Official title: A Twelve-Week, Double Masked, Parallel Group, Primary-Therapy Pilot Study of the Safety and Efficacy of Travoprost 0.004% Compared to Pilocarpine 1% in Patients With Chronic Angle-Closure Glaucoma
The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).
- Conditions
- Angle-closure Glaucoma
- Being tested
- Travoprost 0.004% (Travatan), Pilocarpine 1%
- Keywords
- IOP lowering efficacy, CACG
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost 0.004% (Travatan)Drug
One drop in each eye, once daily at 9 AM
Pilocarpine 1%Drug
One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
| Study group | Role | What they receive |
|---|---|---|
| Travoprost 0.004% (Travatan) | Experimental | One drop in each eye, once daily at 9 AM Receives: Drug: Travoprost 0.004% (Travatan) |
| Pilocarpine 1% | Active comparator | One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks Receives: Drug: Pilocarpine 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP)
Measured: 4PM at Week 12 Visit
Secondary outcomes (1)
Number of Patients With Peripheral Anterior Synechiae (PAS)
Measured: Week 12 Visit
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 startFeb 2007
- Primary completionMay 2008
- Study completionMay 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 Angle-closure 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
- Enrolment
- 30 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
- NCT00762645
- Sponsor's protocol ID
- CM-06-04
- Status last verified
- Mar 2010
- First submitted
- 24 Sep 2008
- Last updated
- 6 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-Week, Double Masked, Parallel Group, Primary-Therapy Pilot Study of the Safety and Efficacy of Travoprost 0.004% Compared to Pilocarpine 1% in Patients With Chronic Angle-Closure Glaucoma
- ClinicalTrials.gov ID
- NCT00762645
- Acronym / sponsor ID
- CM-06-04
- Conditions
- Angle-closure Glaucoma
- Keywords
- IOP lowering efficacy, CACG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 15 Mar 2010
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 that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travoprost 0.004% (Travatan) | Experimental | Drug: Travoprost 0.004% (Travatan)One drop in each eye, once daily at 9 AM |
| Pilocarpine 1% | Active comparator | Drug: Pilocarpine 1%One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Chronic Angle Closure Glaucoma (CACG)
- 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
- Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
- Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
Key exclusion criteria (5 listed)
- Traumatic damage of the anterior chamber angle
- History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
- Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
- Visual Acuity ≥ 1.0
- Contact lenses wearer
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% (Travatan)One drop in each eye, once daily at 9 AM | Drug | Travoprost 0.004% (Travatan) |
| Pilocarpine 1%One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks | Drug | Pilocarpine 1% |
Primary outcome
Mean Intraocular Pressure (IOP)
Time frame: 4PM at Week 12 Visit
1 secondary outcome
Number of Patients With Peripheral Anterior Synechiae (PAS)
Time frame: Week 12 Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- 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.
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 4 study testing Travoprost 0.004% (Travatan) and Pilocarpine 1% in people with Angle-closure Glaucoma, 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 6 inclusion and 5 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 6 Dec 2023. 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 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 15 Mar 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) (time frame: 4PM at Week 12 Visit). 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 6 Dec 2023.