Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00690794
First received: June 3, 2008
Last updated: July 20, 2012
Last verified: July 2012
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Purpose
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Open-angle Glaucoma Ocular Hypertension |
Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point score) used to measure ocular symptoms, visual function and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
Secondary Outcome Measures:
- Percentage of Patients With Corneal Fluorescein Staining Score = 0 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by the total number of patients analyzed.
| Enrollment: | 726 |
| Study Start Date: | July 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Travoprost
One drop self-administered in the study eye(s) once daily for 90 days
|
Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.
Other Name: TRAVATAN Z®
|
|
Active Comparator: Latanoprost
One drop self-administered in the study eye(s) once daily for 90 days
|
Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanprost.
Other Name: XALATAN®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years or older.
- Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
- Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
- Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
- Willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study, including artificial tears.
- Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
- Use of contact lenses within 30 days of Visit 1.
- Use of contact lenses during the study.
- Participation in an investigational drug or device study within 30 days of entering this study.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00690794 History of Changes |
| Other Study ID Numbers: | C-08-03 |
| Study First Received: | June 3, 2008 |
| Results First Received: | March 30, 2012 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Latanoprost Travoprost Cloprostenol |
Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013