Efficacy and Tolerability of GenTeal® Gel in Post-menopausal Women with Moderate to Severe Dry Eye: Results of a Post Marketing Observational Study.
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Date
2012-05
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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.
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Keywords
GenTeal® Gel treatment, Dry eye, Ocular Symptoms, Post-menopausal Women
Citation
Dedhia Niteen C, Gawai Apurva D. Efficacy and Tolerability of GenTeal® Gel in Post-menopausal Women with Moderate to Severe Dry Eye: Results of a Post Marketing Observational Study. Indian Medical Gazette. 2012 May ; 145 (5): 186-192.