Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

Ocular Hypertension Clinical Trial

Official title:

An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761319
• Other study ID #: C-08-047
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2008
• Last updated: April 20, 2012
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: April 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 medicine other than the study medication for the duration of the study, including artificial tears.

• Best corrected visual acuity of -0.6 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

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.
• 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 latanoprost.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score	The OSDI is a 12-question validated questionnaire (resultant overall 0-100 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. A negative number represents a perceived improvement in ocular health.	Day 0, Day 90	No
Secondary	Percentage of Patients With Corneal Fluorescein Staining Score = 0	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 tht total number of patients analyzed.	Day 90	No