Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2011-02-28
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Trav 0.00013%
Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Travoprost Ophthalmic Solution, 0.00013%
Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
Trav 0.00033%
Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Travoprost Ophthalmic Solution, 0.00033%
Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
Trav 0.001%
Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Travoprost Ophthalmic Solution, 0.001%
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Trav 0.00267%
Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Travoprost Ophthalmic Solution, 0.00267%
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
TRAVATAN
Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals)
Travoprost Ophthalmic Solution, 0.004%
Vehicle
Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Travoprost Vehicle
Inactive ingredients used as an active comparator
Interventions
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Travoprost Ophthalmic Solution, 0.00013%
Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.00033%
Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.001%
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.00267%
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.004%
Travoprost Vehicle
Inactive ingredients used as an active comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1;
2. Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1.
* Must sign an informed consent form.
Exclusion Criteria
* Current or history of ocular inflammation or infection in either eye within the past 3 months.
* Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
* Severe visual field loss.
* Cup to disc ratio greater than 0.8 in either eye.
* Intraocular surgery within the past 6 months in either eye.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Matt Walker, PhD
Role: STUDY_DIRECTOR
Alcon Research
Other Identifiers
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C-10-081
Identifier Type: -
Identifier Source: org_study_id
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