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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-02-28

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.

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Doctors assessing patients were masked to treatment. Patients used open label Xalantan in the right eye and Travatan Z in the left eye.

Study Groups

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New to Meds

Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.

Group Type OTHER

Xalatan

Intervention Type DRUG

one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime

Travatan Z

Intervention Type DRUG

one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime

Currently on 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.

Group Type OTHER

Xalatan

Intervention Type DRUG

one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime

Travatan Z

Intervention Type DRUG

one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime

Interventions

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Xalatan

one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime

Intervention Type DRUG

Travatan Z

one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime

Intervention Type DRUG

Other Intervention Names

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prostaglandin analog prostaglandin analog

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No