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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ocular Surface Changes With Topical Prostaglandin Analog Therapy

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Xalatan
* Drug: Travatan Z


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: New to Meds<br>Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. | Drug: Xalatan<br>* one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime<br>* Other names: prostaglandin analog;Drug: Travatan Z<br>* one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime<br>* Other names: prostaglandin analog;|
| Other: Currently on Xalatan<br>Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. | Drug: Xalatan<br>* one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime<br>* Other names: prostaglandin analog;Drug: Travatan Z<br>* one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime<br>* Other names: prostaglandin analog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tear Break up Time (TBUT) | Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment. | Baseline, 1 month, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Production | Tear production, measured by Schirmer test in millimeters | Baseline, 1 month, 2 months | 
| Conjunctival Hyperemia Score | 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). | Baseline, 1 month, 2 months | 
| Intraocular Pressure | Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged. | Baseline, 1 month, 2 months | 
| Ocular Surface Disease Index Score | 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. | Baseline, 1 month, 2 months | 
| Corneal Staining Score | 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). | Baseline, 1 month, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, impression cytology, ocular surface changes, prostaglandins