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

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.

• Xalatan (Drug), also known as prostaglandin analog: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
• Travatan Z (Drug), also known as prostaglandin analog: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime

Primary outcomes

• Change in Tear Break up Time (TBUT) [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

• Tear Production [Baseline, 1 month, 2 months]: Tear production, measured by Schirmer test in millimeters
• Conjunctival Hyperemia Score [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 [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 [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 [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).

Sex: All, ages: 21 Years to any

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

Participant flow

Outcome results

• Change in Tear Break up Time (TBUT) (Primary), Mean, seconds: New to Meds -0.86 +/- 6.09; Currently on Xalatan -0.59 +/- 4.70 (p 0.005)
• Tear Production (Secondary), Mean, millimeters: Group 1 (New to Meds) 22.4 +/- 8.7; Group 2 (Currently on Xalatan) 17.1 +/- 9.3
• Conjunctival Hyperemia Score (Secondary), Mean, units on a scale: Group 1 Xalatan 4.0 +/- 2.7; Group 1 Travatan Z 4.6 +/- 3.3; Group 2 Xalatan 3.2 +/- 2.6; Group 2 Travatan Z 3.6 +/- 3.2
• Intraocular Pressure (Secondary), Mean, mmHg: Group 1 Xalatan 20.9 +/- 7.1; Group 1 Travatan Z 20.1 +/- 6.3; Group 2 Xalatan 14.8 +/- 2.7; Group 2 Travatan Z 15.0 +/- 3.3
• Ocular Surface Disease Index Score (Secondary), Mean, scores on a scale: Group 1 Xalatan 10.8 +/- 14.7; Group 1 Travatan Z 11.7 +/- 14.2; Group 2 Xalatan 9.8 +/- 11.4; Group 2 Travatan Z 14.2 +/- 17.7
• Corneal Staining Score (Secondary), Mean, scores on a scale: Group 1 Xalatan 0.7 +/- 1.0; Group 1 Travatan Z 0.8 +/- 1.0; Group 2 Xalatan 1.0 +/- 1.9; Group 2 Travatan Z 1.0 +/- 1.8

Adverse events

Time frame: Baseline, 1 month, 2 months

Limitations and caveats: Small sample size. Short term study may not reflect long term ocular surface. Patients selected were free of baseline Ocular Surface Disease (OSD). Sample population with pre-existing OSD may have different sensitivity.

• Results publication: 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
• Results publication: 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. PMID 28617732

• Leslie J Katz, MD, Principal investigator, Wills Eye Glaucoma Service