Effects of Travatan Z and Xalatan on Ocular Surface Health

NCT00708422 | Completed Phase 4 Results

• 1 other identifier: SMA-08-07
• Study Type: interventional
• Target: 231
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Ocular surface health; OSDI; TFBUT; Glaucoma; Ocular hypertension; Corneal staining

Outcome Measures

Primary Outcomes (1)

• Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)

  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.

  12 weeks (Day 84)

Secondary Outcomes (1)

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

  12 weeks (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

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

Latanoprost

Eligibility Criteria

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

You may qualify if:

• years of age or older.
• Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
• Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
• IOP controllable and stable on the study medication alone (both eyes).
• Believed to have ocular surface disease (OSD).
• Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
• Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.

You may not qualify if:

• Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
• Current use of punctual plugs.
• Women of childbearing potential not using reliable means of birth control.
• Women who are pregnant or lactating.
• Suspected or diagnosed with Sjogrens's syndrome.
• Current use of any brand of artificial tears containing BAK.
• Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
• Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
• Current use of contact lenses within 30 days of Visit 1.
• Participation in any other investigational study within 30 days prior to Visit 1.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Travoprost; Latanoprost

Condition Hierarchy (Ancestors)

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 Medical Affairs
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

1-800-862-5266

Study Officials

• Judy Vittitoe, RN, MPH

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 2, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 23, 2012
• Results First Posted: April 23, 2012

Record last verified: 2012-03