Back to resultsA 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
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Latanoprost ophthalmic solution 0.005% (XALATAN®)
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Comfort
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travoprost
Latanoprost
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Comfort Immediately After Dosing
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00527592
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Comfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost
Arm Type
Experimental
Arm Description
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.
Arm Title
Latanoprost
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Other Intervention Name(s)
TRAVATAN Z®
Intervention Description
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution 0.005% (XALATAN®)
Other Intervention Name(s)
XALATAN®
Intervention Description
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.
Primary Outcome Measure Information:
Title
Comfort Immediately After Dosing
Description
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
Time Frame
5 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
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
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