Efficacy and Tolerability of GenTeal® Gel in Post-menopausal Women with Moderate to Severe Dry Eye: Results of a Post Marketing Observational Study.

ABSTRACT

Purpose: To assess the effectiveness and tolerability of GenTeal® gel in post-menopausal patients with moderate to severe dry eye. Methods: This was an open label, multicenter, non-comparative, non-interventional, observational study in post-menopausal women patients of age 39-82 years with moderate to severe dry eye. The patients were treated with GenTeal® gel for 20 weeks and assessed for effectiveness at baseline, 10-12 weeks and at 20 weeks. The primary effectiveness outcomes were changes in ocular symptoms (foreign body sensation, itching, burning, watering, photophobia, feeling of dryness in the eye), tear break up time (TBUT), Schirmer, fluorescein corneal staining score and global assessment for efficacy on dry eye condition. The secondary objective of the study was to evaluate ocular tolerance and systemic safety of the product. Results: A total of 169 out of 170 enrolled patients completed the study. At 20 weeks of treatment, the median composite ocular symptoms scores was reduced by 78% from baseline (median; 2.0 vs 9.0 of baseline, p<0.0001). All ocular symptoms except photophobia were significantly reduced (p<0.05) at 20 weeks of treatment. At 20 weeks, TBUT and schirmer scores were significantly increased by 39.9% and 48.6% respectively (p < 0.0001); while fluorescein staining cumulative score was significantly decreased (100.0%, p < 0.0001) from their baseline. The overall efficacy and ocular tolerability of GenTeal® gel, was ‘good’ to ‘excellent’ for >98.0% of the subjects. Adverse events of mild dyspepsia and frequent micturition of moderate intensity were reported by a subject. Conclusions: The findings of the present study indicate that GenTeal® gel treatment is an effective and tolerable treatment for dry eye in post-menopausal women patients in Indian clinical practice.