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

Wills Eye

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: Xalatan; Drug: Travatan Z

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00798694

08-875

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

58 participants in 2 patient groups

New to Meds

Other group

Description:

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

Treatment:

Drug: Travatan Z

Drug: Xalatan

Currently on Xalatan

Other group

Description:

Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.

Treatment:

Drug: Travatan Z

Drug: Xalatan