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

Overview

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 Title of Study: “Ocular Surface Changes With Topical Prostaglandin Analog Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 2011

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.

Interventions

  • Drug: Xalatan
    • one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
  • Drug: Travatan Z
    • one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime

Arms, Groups and Cohorts

  • Other: 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.
  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Tear Production
    • Time Frame: Baseline, 1 month, 2 months
    • Tear production, measured by Schirmer test in millimeters
  • 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).
  • 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.
  • 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.
  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wills Eye
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Principal Investigator: L. Jay Katz MD, Principal Investigator – Wills Eye
  • Overall Official(s)
    • Leslie J Katz, MD, Principal Investigator, Wills Eye Glaucoma Service

Citations Reporting on Results

Gupta SR, Ichhpujani P, Wizov SS, Wittpenn JR, Moster MR, Pro MJ, Rapuano CJ, Cruz-Colon C, Myers JS, Katz LJ. Effects of Latanoprost Versus Travoprost with Sofzia on Ocular Surface. ARVO E-abstract 168/A391 2010

Rahmatnejad K, Rapuano CJ, Ichhpujani P, Wizov SS, Moster MR, Hark LA, Katz LJ. The Effects of Latanoprost With Benzalkonium Chloride Versus Travoprost With SofZia on the Ocular Surface. Eye Contact Lens. 2018 Nov;44 Suppl 2:S93-S98. doi: 10.1097/ICL.0000000000000405.

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