Dry eye<\/strong><\/a> is a multifactorial disease of the tears and the ocular surface, and recognized as a growing public health problem1-4. According to the report of the Epidemiology Subcommittee of the 2007 Dry Eye Work Shop, 14% -33% of the population worldwide suffers from dry eye5. The prevalence of dry eye disease for people e\u201d 50 years is more among women (7.8%) than in men (4.7%) in the US2, 6. Dry eye is caused by a deficiency in the quantity and\/or quality of tears, an unstable tear film and ocular surface damage leading to symptoms such as ocular\u00a0 irritation, dryness, fatigue, and fluctuating visual\n disturbances7.<\/p>\nAmong the various risk factors associated with dry eye increasing age, female gender, androgen deficiency and hormone replacement therapy4 are vital for development of dry eye disease8. In post-menopausal women, conjunctival\n epithelium morphology is modified by estrogen deficiency, in particular by reducing the density of goblet cells responsible for mucous secretion, leading to instability of the tear film and dryness9.<\/p>\n
The Currently recommended therapies for dry eye disease are lifestyle changes and the use of artificial tears products, anti-inflammatory medications or surgery10-13. These therapies however, alleviate symptoms but provides only temporary relief and blurring of vision leading to poor compliance14. The therapeutic goal is to control of the disease process in order to preserve vision and to provide comfort15.<\/p>\n
GenTeal\u00ae <\/em><\/strong>gel (0.3% HPMC, 0.22% carbomer gel) is long-acting eye gel that has been approved by the US FDA for treatment of moderate to severe dry eye disease16. GenTeal\u00ae <\/em><\/strong>gel has disappearing preservative, sodium perborate which breaks down into water and oxygen upon contact with the tear film and ocular tissue thus lets patients with preservative sensitivities.<\/p>\nPreviously, clinical trials have demonstrated the efficacy and tolerability of GenTeal\u00ae <\/em><\/strong>gel for treatment of dry eye disease in the United States17-18. It lubricates the surface of the eye with minimal blurring of vision as well as provides superior relief from the signs and symptoms of dry eye as in contrast to aqueous artificial tear substitutes. Additional evidence is needed to verify the effectiveness and tolerability of GenTeal\u00ae gel in moderate to severe dry eye disease among post-menopausal women. Thus the present open label, non comparative study was designed to assess the efficacy and tolerability of GenTeal\u00ae gel in post-menopausal women with moderate to severe dry eye disease prescribed\u00a0 during routine clinical practice in India.<\/p>\n\nMethods<\/h2>\n
Study design and patients<\/strong><\/p>\nThis was an open label, multi-center, non-comparative, non-interventional, 20 weeks observational study in India.<\/p>\n
The study was performed in 170 post-menopausal women of age between 39-82 years with moderate to severe dry eye. Post- menopause was defined as absence of menstrual period for at least one year, or surgical hysterectomy with bilateral oophorectomy, no less than six months prior to the study. The subjects enrolled were either drug na\u00efve patients or those who were previously treated with or on any other tear substitute when in the ophthalmologist\u2019s opinion, they would benefit from GenTeal\u00ae <\/em><\/strong>Gel. The study was conducted according to the ethical principles of the Declaration of Helsinki and was approved by the Independent Ethics Committee or Institutional Review Board for each center. A written informed consent was obtained from all subjects prior to participation in the study.<\/p>\nTreatment and assessments<\/h2>\n
Patients, who were on any other tear substitute, the usages of existing tear substitute was stopped, and switched to GenTeal\u00ae <\/em><\/strong>gel. Patients were prescribed GenTeal\u00ae <\/em><\/strong>gel and instructed to instill 1-2 drops of GenTeal\u00ae <\/em><\/strong>gel 2 to 4 times
\n daily for 20 weeks in the conjunctival cul-de-sac of both eyes. The dose selection was based on the ophthalmologist\u2019s current clinical practice. No other tear substitute other than GenTeal\u00ae <\/em><\/strong>gel was allowed from enrollment until the end of study. The patients were assessed at three different visits at baseline (Day 0), (week 10-12) and at week 20.<\/p>\nThe primary efficacy of the study was evaluated by assessing the change in dry eye symptoms calculated as individual symptom scores [(foreign body sensation, itching, burning, watering, photophobia and feeling of dryness in the eye); each on a scale 0-3; none (0), mild (1), moderate (2), severe (3)] and composite symptoms score which ranged from 0-18. In addition dry eye signs (i.e.; TBUT, Schirmer\u2019s test, fluorescein corneal staining)19 were also performed at the discretion of the ophthalmologist from baseline and at week 20. The global assessment of treatment efficacy on dry eye conditions (i.e. Excellent, Good, Fair, Poor) was also assessed by the ophthalmologist as well as by the subjects.<\/p>\n
The secondary objective of the study was to evaluate ocular tolerance and systemic safety of the product through global assessment of tolerability by the ophthalmologist & by the subjects: Ocular tolerance was assessed by enquiring about and recording ocular discomfort that occurred in relation to instillation of the study medication using a defined grading (e.g. excellent, good, fair, poor) and systemic safety was evaluated from AE reporting. Both the efficacy and safety variables were measured at all the visits.<\/p>\n\n
Table 1<\/strong>
Demographie summary of the patients<\/th><\/tr>\n| <\/td> | <\/td> | GenTeal\u00ae Gel treatment N=170<\/td><\/tr>\n | | Age (years)<\/td> | Mean \u00b1 SD<\/td> | 56.6\u00b1 9.42<\/td><\/tr>\n | \n | <\/td>\n | Median<\/td>\n | 54.0<\/td>\n<\/tr>\n | \n | <\/td>\n | Range<\/td>\n | 39.0-82.0<\/td>\n<\/tr>\n | \n | Age group – n (%)<\/td>\n | 35-44 years<\/td>\n | 11 (6.47%)<\/td>\n<\/tr>\n | \n | <\/td>\n | 45-54 years<\/td>\n | 74 (43.5%)<\/td>\n<\/tr>\n | \n | <\/td>\n | 55-64 years<\/td>\n | 51 (30.0%)<\/td>\n<\/tr>\n | \n | <\/td>\n | 75-85 years<\/td>\n | 12 (7.06%)<\/td>\n<\/tr>\n | \n | <\/td>\n | Other*<\/td>\n | 3 (1.76%)<\/td>\n<\/tr>\n | \n | Gender-n (%)<\/td>\n | Female<\/td>\n | 170 (100%)<\/td>\n<\/tr>\n<\/table>\n\nStatistical analysis<\/h2>\nAnalysis for efficacy and safety was performed for all evaluable patients. One-way ANOVA was applied for ocular signs (i.e. tear breakup time, Schirmer\u2019s test score and Fluorescein staining) between various time intervals. Chisquare test was used for analysis of dry eye symptoms at various time intervals. All statistical tests were applied using SAS statistical software (version 9.) 2 and the p value of <\n0.05 were considered statistically significant. <\/p>\n\n Results<\/h2>\nPatients<\/h3>\nOf the 170 enrolled subjects, 169 completed the study and 1 subject discontinued from the study due to lost to follow up. The mean age of the 170 female subjects enrolled into the study was 56.6 \u00b1 9.42 years with 12 subjects were more than 74 years of age. The demographic and other baseline details of signs and symptoms are given in Tables 1 & 2.<\/p>\n\n Efficacy<\/h3>\nTreatment with GenTeal\u00ae gel by post menopausal women with dry eye syndrome for 20 weeks significantly reduced (p<0.0001) the composite score of dry eye symptoms (Table 3, Fig. 1a). All the symptoms of dry eye\n(i.e. burning sensation, foreign body sensation, itching, watering of eyes and dryness) except photophobia were significantly reduced at 20 weeks of treatment (Table 3). All the symptoms showed a decreasing pattern from baseline, at 10 weeks and at 20 weeks.<\/p>\n A significant improvement was observed in the dry eye signs with GenTeal\u00ae gel treatment over 20 weeks (Table 4). There was a significant increase in tear breakup\ntime and Schirmer\u2019s test score (p<0.0001) with significant decrease in Fluorescein staining cumulative score (p<0.0001) (Table 4, Fig. 1b). The overall efficacy with GenTeal\u00ae gel treatment for 20 weeks was \u2018good\u2019 to \u2018excellent\u2019 for >99% of the subjects as per both the physician\u2019s and the subject\u2019s assessment (Table 5).<\/p>\n | |
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