Effects of Xalatan® (latanoprost) or Travatan® (travoprost) on Ocular

Surface Signs and Symptoms in Ocular Hypertensive or Glaucoma Patients.

M.B. McDonald1, R.T. Sturm6, R.M. Caronia6, P.R. Galstian6, G. D'Aversa3, R.G. Fumuso2, E.D. Donnenfeld1, H.D. Perry2, J.R. Wittpenn, Jr.5, J.K. Oats5, M.A.

Swerdin3, D.M. Sachs4, R.E. Mariani6. 1Ophthalmology, Ophthalmic Consultants of Long Island, Lynbrook and Rockville Centre, NY;

2Ophthalmology, Ophthalmic Consultants of Long Island, Rockville Centre, NY; 3Ophthalmology, Ophthalmic Consultants of Long Island, Valley Stream, NY; 4Ophthalmology, Ophthalmic Consultants of Long Island, East Meadow, NY;

5Ophthalmology, Ophthalmic Consultants of Long Island, Stony Brook, NY; 6Ophthalmology, Ophthalmic Consultants of Long Island, Lynbrook, NY

The authors of this poster have received research funding from Pfizer Inc.

Revised AbstractPurpose: Burning and stinging associated prostaglandin instillation are associated with treatment failures due to non-compliance, it is worse in patients with dry eye. This pilot study examines potential differences in the ocular signs and symptoms in patients treated with either latanoprost or travoprost, based subjective and clinical assessments.

Methods: The study includes up to 40 patients (80 eyes) with ocular hypertension or glaucoma with mild to moderate dry eye (≤Grade 3, Oxford Grading Scale) enrolled to complete four visits over two months. Initially, screened patients are allowed 4-28 days to washout of their current medication after which patients are randomized to receive either drug (baseline). Patients follow treatment regimen until exit at day 56. Primary endpoint is the OSDI scores (patient’s subjective assessment) while secondary endpoints are clinical: TBUT, corneal assessment, lissamine green staining, and slit-lamp exam. All evaluations are performed by a masked investigator. ANOVA was performed to compare treatment outcomes.

Results: At day 56, both treatments did not have a significant impact on OSDI when compared to baseline (p=0.7 for travoprost and p=0.9 for latanoprost, n=5/group). TBUT remained unchanged for latanoprost (p=0.9, n=5), but was significantly lower than baseline after travoprost treatment (p=0.04, n=5). Tear flow remained statistically unchanged after travoprost (p=0.2, n=5) or latanoprost (p=0.5, n=5) treatment. BCVA after travoprost and latanoprost treatment was not affected (p=0.9 for travoprost and p=0.7 for latanoprost, n=5/ group). Central corneal grading (p=0.2, n=5), lissamine staining (p=0.6, n=5) and slit lamp biomicroscopy (p=0.4, n=5) scores remained unchanged when compared to baseline. In an ongoing study, Travatan Z® (travoprost) is also compared to latanoprost. Preliminary results indicate no significant differences in OSDI scores between treatment groups (p>0.2, n=4).

Conclusions: In this interim report. travoprost or latanoprost treatments did not statistically change patients subjective assessment. The only statistically significant finding was after travoprost treatment, TBUT decreased (worsened) over the treatment period (p=0.04, n=5). Studies are currently ongoing to compare Travatan Z® (travoprost) to latanoprost.

Introduction

• Prostaglandins are a popular choice for treatment of ocular hypertension or glaucoma because of their clinical efficacy and once-daily dosing schedule.

• Unfortunately the burning and stinging associated with their instillation contributes to treatment failures due to non-compliance, which is worse in patients with dry eye.

• This pilot study examines potential differences in the ocular signs and symptoms in patients treated with either latanoprost or travoprost, based subjective and clinical assessments.

Methods• This initial study was performed with 5 patients in each treatment group

and is set to enroll 40 patients (80 eyes). • Patients with ocular hypertension or glaucoma with mild to moderate

dry eye (≤Grade 3, Oxford Grading Scale) were enrolled to complete four visits over two months.

• At the 1st visit, screened patients are allowed 4-28 days to washout of their current medication.

• The 2nd visit is the baseline where patients are randomized to receive either Xalatan® (latanoprost ophthalmic solution) or Travatan® (travoprost ophthalmic solution) .

• Patients follow treatment regimen until exit at day 56. • Primary endpoint is the OSDI scores (patient’s subjective assessment).• Secondary endpoints are clinical: TBUT, corneal assessment, lissamine

green staining, and slit-lamp exam. • All evaluations are performed by a masked investigator. • ANOVA was performed to compare treatment outcomes.

Results

•Both treatments had no statistically significant impact on OSDI scores.•There were no significant differences in OSDI scores over the treatment

period compared to baseline (p=0.7 for Travatan® and p=0.9 for Xalatan®, n=5 per group).•The lower the OSDI score the lower the dry eye related disease severity.

Worse

Better

Results

•TBUT remained unchanged for Xalatan® (p=0.9, n=5).

•* On visit 4, TBUT was significantly lower than baseline after Travatan® treatment (p=0.04, n=5).

Worse

Better

*(P=0.04, n=5)

Results

• Tear flow remained statistically unchanged after Travatan® (p=0.2, n=5) or Xalatan® (p=0.5, n=5) treatment over the treatment period.

Worse

Better

Results

• BCVA was measured using the logMAR (minimum angle of resolution).

• BCVA after Travatan® and Xalatan® treatment was not affected (p=0.9 for Travatan® and p=0.7 for Xalatan®, n=5 per group).

Vision Loss

Better Visual Acuity

Results

Secondary Evaluation Criteria

• After visit 4 (56 days after treatment with either Travatan® or Xalatan®), secondary evaluation criteria such as central corneal grading (p=0.2, n=5), lissamine staining (p=0.6, n=5) and slit lamp biomicroscopy (p=0.4, n=5) scores remained unchanged when compared to baseline.

Results

• In an ongoing study, Travatan Z® is also compared to Xalatan®.

• Preliminary OSDI scores measured at final patient visit (visit 4) indicate no statistically significant differences between treatment groups (p>0.2, n=4).

• The lower the OSDI score the lower the dry eye related disease severity.

Worse

Better

Conclusions

• In this interim report, Travatan® and Xalatan® treatments, did not statistically change the patients subjective assessment.

• The only statistically significant finding was in the Travatan® treatment group, where TBUT decreased (worsened) over the treatment period (p=0.04, n=5).

• Studies are currently ongoing to compare Travatan Z® to Xalatan®.