Dry Eye and Irritation Comparison of Latanoprost With the Preservative Versus Travoprost Without Preservative

NCT00803387 | Completed

• 1 other identifier: FWH20080020H
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Although Benzalkonium chloride (BAC) has been used as a preservative for many years, many studies have demonstrated that prolonged use of topical ocular medications preserved with BAC may exacerbate sequelae associated with ocular surface disease. These effects could lead to the induction of subclinical inflammation,1 reduction of corneal epithelial barrier function, 2, 3 destabilization of the tear film, 4 cataract formation, 5 and an overall higher incidence of patient complaints of dryness and irritation. 4-6 This study will compare the efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of latanoprost 0.005%with BAC in patients with dryness and irritation and open-angle glaucoma or ocular hypertension. A double blind comparison will be used to assess whether those two different formulations will affect the tear breakup times, corneal staining, and baseline tear secretion tests in patients that are already taking latanoprost regularly with complaints of dryness and irritation. Patients included in the study will be given two bottles, one labeled for their right eye and the other for their left eye. Each pair of bottles will be identical in appearance and randomized with either latanoprost or travoprost and each pair will be assigned a number to aid in future analysis of the final results.

Conditions

Ocular Dryness; Ocular Irritation; Open-Angle Glaucoma; Ocular Hypertension

Keywords

ocular dryness; ocular irritation; open-angle glaucoma; ocular hypertension; TravatanZ; Xalatan

Outcome Measures

Primary Outcomes (1)

• Routine eye exams in addition to Ocular Surface Disease Index (OSDI) surveys at the beginning and end of the study. Patients will also be asked to rate their extent of dryness and irritation of either eye on a scale of 1-10 at each visit.

  Each patient will be followed every 3-4 weeks for 3 months

Study Arms (1)

Patients taking Xalatan with ocular dryness or irritation

* patient must already be using xalatan for at least 1 month prior to study enrollment in both eyes and have complaints of dry eye and/or irritation. * any race and of either sex, diagnosed with open angle glaucoma (OAG) (with or without pseudoexfoliation or pigment dispersion components) or ocular hypertension (OHT)

Drug: Travaprost without BAC (Travatan Z)

Interventions

Travaprost without BAC (Travatan Z) DRUG

A double blind comparison was used to assess whether Xalatan or TrvatanZ affects the tear breakup times, corneal staining, and baseline tear secretion tests in patients that are already taking latanoprost regularly with complaints of dryness and irritation. Patients included in the study will be given two bottles, one labeled for their right eye and the other for their left eye. Each pair of bottles will be identical in appearance and randomized with either latanoprost or travoprost and each pair will be assigned a number to aid in future analysis of the final results. One Drop from both bottles will be dispensed in the respective eye once a day.

Patients taking Xalatan with ocular dryness or irritation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Must be eligible for care at WHMC ie active duty, military retirees and their dependents * patient must already be using xalatan for at least 1 month prior to study enrollment in both eyes and have complaints of dry eye and/or irritation. * any race and of either sex, diagnosed with open angle glaucoma (OAG) (with or without pseudoexfoliation or pigment dispersion components) or ocular hypertension (OHT) * tear break up times (TBUT) \< 6 seconds on xalatan monotherapy.

You may qualify if:

• patient must already be using xalatan for at least 1 month prior to study enrollment in both eyes and have complaints of dry eye and/or irritation.
• study population:
• any race and of either sex, diagnosed with open angle glaucoma (OAG) (with or without pseudoexfoliation or pigment dispersion components) or ocular hypertension (OHT)
• tear break up times (TBUT) \< 6 seconds on xalatan monotherapy.

You may not qualify if:

• unequal baseline measurements (i.e. difference in cup to disc ratio of .1 or greater, intraocular pressure difference of 2 or more mm Hg),
• difference in subjective symptoms of dryness/irritation between the patient's two eyes;
• history of ocular trauma or intraocular surgery within the past 6 months in either eye;
• ocular infection, ocular inflammation, or ocular laser surgery within the past 3 months in either eye;
• severe hypersensitivity to study medications or vehicle;
• any abnormality preventing reliable applanation tonometry;
• anterior chamber angle less than 10 degrees in either eye,
• severe central visual field loss in either eye;
• cup-to-disc ratio greater than 0.80 in either eye;
• contraindications to pupil dilation; previous diagnosis of autoimmune diseases;
• chronic glucocorticoid use within 1 month of and during the eligibility phase or intermittent glucocorticoid use within 2 weeks of the eligibility phase;
• any type of glaucoma other than OAG or OHT;
• therapy with another investigational agent within 30 days of study start;
• use of any other topical or systemic ocular hypotensive medication during the study.

Sponsors & Collaborators

• United States Air Force: lead
• Alcon Research: collaborator

Study Sites (1)

WHMC

Lackland Air Force Base, Texas, 78236, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bacitracin; Travoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• James R Townley, MD

  United States Air Force

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 5, 2008

Record last verified: 2008-12

Locations

US (1)