- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00527592
A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
May 11, 2012 updated by: Alcon Research
The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older.
- Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
- Best corrected visual acuity of 20/200 Snellen or better in each eye.
- Intraocular pressure within protocol-specified range.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any abnormality preventing reliable applanation tonometry in the study eye(s).
- Any eye conditions or procedures as specified in protocol.
- Progressive retinal or optic nerve disease from any cause.
- Use of contact lenses in the study eye(s).
- Other protocol-defined exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Travoprost
Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
One drop, single dose.
The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
|
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose.
Referred to as travoprost.
Other Names:
|
Active Comparator: Latanoprost
Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control.
One drop, single dose.
The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
|
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose.
Referred to as latanoprost.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort Immediately After Dosing
Time Frame: 5 seconds
|
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
|
5 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
September 10, 2007
First Submitted That Met QC Criteria
September 10, 2007
First Posted (Estimate)
September 11, 2007
Study Record Updates
Last Update Posted (Estimate)
May 18, 2012
Last Update Submitted That Met QC Criteria
May 11, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMA-07-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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