How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?

Phase 4

Completed

Conditions: Glaucoma

Interventions: Drug: Xalatan
Drug: Travatan Z

Registration Number: NCT00798694

Lead Sponsor: Wills Eye

Brief Summary: To determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan Z.

Detailed Description: Two groups will be entered into this study: group 1 will be naive to treatment and group 2 will be using Xalatan for at least one month before enrollment. Both groups will be using one drop at bedtime of Xalatan in the right eye and one drop at bedtime of Travatan Z in the left eye. Both of these drops are presently on the market and approved by the FDA for treatment of lowering eye pressure. Because this study will be masked, the examining clinician will not know what study drop each patient has been using.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

Inclusion Criteria

Age 21 or older
Able to understand protocol and agree to 3 visits
Any type of glaucoma
Selective laser trabeculoplasty, Argon laser trabeculoplasty, peripheral iridotomy accepted
Naïve: No prior glaucoma treatment (medical or surgical)
If patient non-compliant, must be off meds 3 months
Xalatan: At least one month use

Exclusion Criteria

Both Groups: Any history of ocular surface disease
Dry eye syndrome or prior Restasis use
Prior ocular surgery other than cataract extractions
Uveitis or other inflammatory disease of the eye or adnexa
Systemic medications that might influence ocular inflammation
Any active inflammation or infection
Pregnancy or intention to become pregnant
Naïve: Prior use of topical glaucoma medication unless off for 3 months.
Use of preserved artificial tear preparations in last 30 days and more than one year history of chronic use
Xalatan: Prior use of Travatan or Travatan Z

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New to Meds	Xalatan	Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
New to Meds	Travatan Z	Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Currently on Xalatan	Travatan Z	Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Currently on Xalatan	Xalatan	Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.

Primary Outcome Measures

Name	Time	Method
Change in Tear Break up Time (TBUT)	Baseline, 1 month, 2 months	Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.

Secondary Outcome Measures

Name	Time	Method
Tear Production	Baseline, 1 month, 2 months	Tear production, measured by Schirmer test in millimeters
Intraocular Pressure	Baseline, 1 month, 2 months	Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged.
Conjunctival Hyperemia Score	Baseline, 1 month, 2 months	Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness).
Ocular Surface Disease Index Score	Baseline, 1 month, 2 months	Ocular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time.
Corneal Staining Score	Baseline, 1 month, 2 months	Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness).