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OpenTrials
Completed

NCT Number: NCT00798694

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

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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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xalatan

Drug

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

Other names: prostaglandin analog

Travatan Z

Drug

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

Other names: prostaglandin analog

Primary outcomes

  1. Change in Tear Break up Time (TBUT)

    Time frame: 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 outcomes

  1. Tear Production

    Time frame: Baseline, 1 month, 2 months

    Tear production, measured by Schirmer test in millimeters

  2. Conjunctival Hyperemia Score

    Time frame: 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).

  3. Intraocular Pressure

    Time frame: 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.

  4. Ocular Surface Disease Index Score

    Time frame: 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.

  5. Corneal Staining Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Pfizer

Registry information

Official study title

Ocular Surface Changes With Topical Prostaglandin Analog Therapy

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 26, 2008
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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