Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN

NCT00798759 | Completed Phase 4 Results

• 1 other identifier: C-08-050
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this 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 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)

  Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.

  Day 0, Day 84

Secondary Outcomes (1)

• Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score

  Day 0, Day 84

Study Arms (2)

Travoprost

EXPERIMENTAL

One drop self-administered in the study eye(s) once daily at night for 12 weeks

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 at night for 12 weeks

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 12 weeks (84 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 12 weeks (84 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.
• Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
• Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
• Best corrected visual acuity of -0.6 logMAR or better in each eye.

You may not qualify if:

• Treatment with BAK preserved artificial tears within 30 days of Visit 1.
• Known or suspected Sjogren's disease.
• Uncontrolled IOP.
• History or evidence of infectious or inflammatory ocular conditions.
• Progressive retinal or optic nerve disease.
• Ocular laser surgery within 3 months of Visit 1.
• Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
• Current use of punctal plugs or punctal cautery.
• Use of systemic medications that has not been stable for 30 days prior to Visit 1.
• Use of contact lens within 30 days of Visit 1.

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 26, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 1, 2012
• Results First Posted: April 23, 2012

Record last verified: 2012-05