Pediatric GlaucomaPhase 3NCT01652664
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
A Phase 3 study testing Travoprost 0.004% PQ ophthalmic solution and Timolol, 0.5% or 0.25% ophthalmic solution in people with Pediatric Glaucoma and Elevated IOP in Pediatric Patients, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
- What is being tested?
- Travoprost 0.004% PQ ophthalmic solution and Timolol, 0.5% or 0.25% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Mar 2014
- Phase
- Phase 3
- 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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of pediatric glaucoma or ocular hypertension.
- Qualifying mean IOP at the Eligibility Visit in at least one eye.
- Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures.
- History of chronic, recurrent or severe inflammatory eye disease.
- Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
- Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
- Clinically significant or progressive retinal disease.
- Severe ocular pathology (including severe dry eye) that, in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker.
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- Intraocular surgery in the study eye within 30 days prior to the Screening Visit.
- Any abnormality preventing reliable applanation tonometry.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.
- Conditions
- Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
- Being tested
- Travoprost 0.004% PQ ophthalmic solution, Timolol, 0.5% or 0.25% ophthalmic solution, Travoprost Vehicle
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost 0.004% PQ ophthalmic solutionDrug
Timolol, 0.5% or 0.25% ophthalmic solutionDrug
Patients 2 months to < 3 years of age received 0.25%
Travoprost VehicleDrug
Inactive ingredients used to maintain masking
| Study group | Role | What they receive |
|---|---|---|
| Travoprost | Experimental | Travoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months Receives: Drug: Travoprost 0.004% PQ ophthalmic solution; Drug: Travoprost Vehicle |
| Timolol | Active comparator | Timolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months Receives: Drug: Timolol, 0.5% or 0.25% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in IOP at Month 3
IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.
Measured: Baseline (Day 0), Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionMar 2014
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 Pediatric 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
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Subha Venkataraman, Clinical Project Lead, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652664
- Sponsor's protocol ID
- C-12-008
- Status last verified
- Jun 2015
- First submitted
- 26 Jul 2012
- Last updated
- 23 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01652664
- Acronym / sponsor ID
- C-12-008
- Conditions
- Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Posted 13 Apr 2015
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 Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travoprost | Experimental | Drug: Travoprost 0.004% PQ ophthalmic solution, Drug: Travoprost VehicleTravoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months |
| Timolol | Active comparator | Drug: Timolol, 0.5% or 0.25% ophthalmic solutionTimolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of pediatric glaucoma or ocular hypertension.
- Qualifying mean IOP at the Eligibility Visit in at least one eye.
- Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (9 listed)
- Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures.
- History of chronic, recurrent or severe inflammatory eye disease.
- Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
- Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
- Clinically significant or progressive retinal 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% PQ ophthalmic solution | Drug | Travoprost |
| Timolol, 0.5% or 0.25% ophthalmic solutionPatients 2 months to < 3 years of age received 0.25% | Drug | Timolol |
| Travoprost VehicleInactive ingredients used to maintain masking | Drug | Travoprost |
Primary outcome
Mean Change From Baseline in IOP at Month 3
Time frame: Baseline (Day 0), Month 3
IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- 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.
Subha Venkataraman, Clinical Project Lead study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Travoprost 0.004% PQ ophthalmic solution and Timolol, 0.5% or 0.25% ophthalmic solution in people with Pediatric Glaucoma and Elevated IOP in Pediatric Patients, 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 9 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 23 Jul 2015. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2015). 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 Change From Baseline in IOP at Month 3 (time frame: Baseline (Day 0), Month 3). 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 23 Jul 2015.