Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

NCT00761319 | Completed Phase 3 Results

• 1 other identifier: C-08-047
• Study Type: interventional
• Target: 705
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Open-angle Glaucoma; Ocular Hypertension

Keywords

Open-angle glaucoma; ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Percentage of Patients With Corneal Fluorescein Staining Score = 0

  Day 90

Study Arms (2)

Travoprost

EXPERIMENTAL

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®)

Latanoprost

ACTIVE COMPARATOR

One drop self-administered in the study eye(s) once daily for 90 days

Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)

Interventions

Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) DRUG

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.

Also known as: TRAVATAN Z®

Travoprost

Latanoprost ophthalmic solution 0.005% (XALATAN®) DRUG

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.

Also known as: XALATAN®

Latanoprost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost; Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

The subjective nature of the OSDI may not be sensitive enough to detect the effects of preservatives on the corneal surface. The measurement and quantification of OSD remains a considerable clinical challenge. (Pflugfelder and Baudoin, 2011)

Results Point of Contact

• Title: Director of Alcon Clinical
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 29, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 26, 2012
• Results First Posted: April 23, 2012

Record last verified: 2012-04