Evaluation of Insulin Eye Drops in Diabetic Dry Eye Patients
- Conditions
- Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
- Registration Number
- CTRI/2021/11/038214
- Lead Sponsor
- Dr R P Centre for Ophthalmic Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Type II Diabetic patients, >18 years of age, diagnosed with mild-moderate dry eye and consenting to participate in the study shall be enrolled.
2. Dry eye shall be diagnosed based on Ocular Surface Disease Index (OSDI) score greater than 13, and TBUT < 10 seconds or Schirmer I score <10 mm.
1.Patients with severe dry eye ; OSDI >33
2. Schirmer I test less than 5 mm in either eye at screening.
3.Patients with any uncontrolled severe systemic disease that may affect the eye (other than Diabetes Mellitus).
4.Patients with use of any systemic medication that may affect tear film or vision within 3 months of screening .
5.Any ocular/ophthalmic surgery or trauma, which could affect corneal sensitivity and/or tear distribution within 6 months prior to screening.
6.Current or previous use of topical ocular medication within 2 weeks of screening and use of contact lens anticipated during the study or use 3 months prior to screening.
7.Patients with raised intraocular pressure on screening and known cases of glaucoma shall also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OSDI symptom scoreTimepoint: At 6 months
- Secondary Outcome Measures
Name Time Method Change in ocular surface stabilty ( TBUT, Schirmer,lipid layer thickness, tear meniscus height) <br/ ><br>Meibography <br/ ><br>Corneal nerve morphology on confocal microscopy <br/ ><br>Tear Osmolarity <br/ ><br>Tear inflammatory cytokine levels <br/ ><br>Tear glucose levelsTimepoint: At 6 months