MOIST EYE STUDY: Evaluation of Efficacy, and Tolerability of GenTeal® Gel [(ophthalmic gel) (0.3% hypromellose (Hydroxypropylmethylcellulose); 0.22% carbomer)] in the treatment of moderate to severe dry eye in post menopausal Indian women

Evaluation of Efficacy, and Tolerability of GenTeal® Gel [(ophthalmic gel) (0.3% hypromellose (Hydroxypropylmethylcellulose); 0.22% carbomer)] in the treatment of moderate to severe dry eye in post menopausal Indian women

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003033

Enrollment

200

Registered

2011-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Genteal Gel: Gel to be instilled in dry eye,2-4 times per day for 20 week study Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Post-menopausal women with moderate to severe dry eye. Post- menopause is 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 clinician has to use his/her clinical judgement in assessing whether the patient has developed a moderate to severe dry eye. A guide will be provided to the clinician with the diagnostic criteria of dry eye state. 2. Study participants must give written Informed Consent prior to the study (for data protection reasons)

Exclusion criteria

Exclusion criteria: NIL

Design outcomes

Primary

Measure	Time frame
The primary objective is to assess the efficacy of GenTeal® Gel in moderate to severe Dry Eye in post menopausal Indian women after using GenTeal® Eye Gel for 20 weeks.Timepoint: Visit 01:Baseline. Visit 02: At week 10 (+/- 2weeks) Visit 03 (close out):At week 20 ( +/- 2 weeks)	—

Secondary

Measure	Time frame
Secondary objective is to assess tolerability of GenTeal® Eye Gel in moderate to severe Dry Eye in post menopausal Indian women after using GenTeal® Eye Gel for 20 weeks.Timepoint: Visit 1: At baseline Visit 2: Week 10 (+/- 2 weeks) Visit 3(close out): Week 20 (+/- 2 weeks)	—

Countries

India

Contacts

Public ContactDr Sameer Guliani

Medical Advisor

sameer.guliani@novartis.com02224958888

Outcome results