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

Glaucoma Clinical Trial

Official title:

Ocular Surface Changes With Topical Prostaglandin Analog Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798694
• Other study ID #: 08-875
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: February 2011

Study information

• Verified date: July 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	Wills Eye Glaucoma Service	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 2017 Jun 14. doi: 10.1097/ICL.0000000000000405. [E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tear Break up Time (TBUT)	Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.	Baseline, 1 month, 2 months
Secondary	Tear Production	Tear production, measured by Schirmer test in millimeters	Baseline, 1 month, 2 months
Secondary	Conjunctival Hyperemia Score	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).	Baseline, 1 month, 2 months
Secondary	Intraocular Pressure	Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged.	Baseline, 1 month, 2 months
Secondary	Ocular Surface Disease Index Score	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.	Baseline, 1 month, 2 months
Secondary	Corneal Staining Score	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).	Baseline, 1 month, 2 months