Clinical trial NCT00798694: How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
Official title: Ocular Surface Changes With Topical Prostaglandin Analog Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: glaucoma
impression cytology
ocular surface changes
prostaglandins
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-11-26
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Tear Break up Time (TBUT)
timeFrame: Baseline, 1 month, 2 months
Secondary outcomes:
measure: Tear Production
timeFrame: Baseline, 1 month, 2 months
measure: Conjunctival Hyperemia Score
timeFrame: Baseline, 1 month, 2 months
measure: Intraocular Pressure
timeFrame: Baseline, 1 month, 2 months
measure: Ocular Surface Disease Index Score
timeFrame: Baseline, 1 month, 2 months
measure: Corneal Staining Score
timeFrame: Baseline, 1 month, 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye Glaucoma Service
name: Leslie J Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.