Abstract
Purpose: :
Although prostaglandins are a popular treatment option for ocular hypertension or glaucoma, burning and stinging associated with their instillation contributes to treatment failures due to non-compliance. It is worse in patients (PTS) with dry eye. This study examines differences in the ocular signs and symptoms in PTS treated with either latanoprost or travoprost, based subjective and clinical assessments.
Methods: :
A total of 21 PTS /group with ocular hypertension or glaucoma with mild to moderate dry eye (≤Grade 3, Oxford Grading Scale) completed this masked study. Screened PTS are allowed 28 days for washout at the 1st visit, and then randomized to receive either drug at the 2nd visit (baseline). Treatment regimen is followed until exit at day 56. Primary endpoint is the PTS subjective assessment, the Ocular Surface Disease Index (OSDI) score, while secondary endpoints are clinical: Tear breakup time (TBUT), Schirmer’s test, corneal assessment, lissamine green staining, and slit-lamp exam (SLE). All evaluations were performed by a masked investigator. Student's t-test was performed to compare treatment outcomes.
Results: :
After 4 wk latanoprost treatment, OSDI scores significantly improved from baseline 9.5±2.3 to 4.3±1.2 (p=0.002) though TBUT decreased significantly from 4.9±0.2 to 3.8±0.3 sec (p=0.003). After 4 wk travoprost treatment, OSDI score of 10.2±1.9 was not significantly different from baseline of 12.4±2.2 (p=0.7). TBUT was 4.5±0.1 sec at baseline and was unchanged, 4.2±0.3 sec, after 4 wks (p=0.3). Unlike latanoprost treatment, travoprost treatment significantly increased Schirmer’s scores from 7.5±0.4 mm to 10.5±0.8 mm (p=0.002). Baseline OSDI scores were similar for both groups, but after 4 wks, latanoprost significantly improved OSDI scores compared to travoprost (p=0.02). SLE, central corneal grading and lissamine staining scores were unchanged after both treatments.
Conclusions: :
Unlike PTS treated with travoprost, PTS treated with latanoprost reported significant improvement in their subjective assessment compared to travoprost based on OSDI scores, the primary endpoint. All but two secondary end points, TBUT and Schirmer’s scores, remained unchanged in both groups compared to baseline.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00799682
Keywords: ocular irritancy/toxicity testing • anterior segment • drug toxicity/drug effects