Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: Topical Insulin eye drops (1 IU/mL): Topical Insulin eye drops (1 IU/mL) prepared in artificial tears with polyethylene glycol and polypropylene glycol base.
Control Intervention1: Arti
Sponsors
Dr R P Centre for Ophthalmic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSDI symptom scoreTimepoint: At 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ocular surface stabilty ( TBUT, Schirmer,lipid layer thickness, tear meniscus height) Meibography Corneal nerve morphology on confocal microscopy Tear Osmolarity Tear inflammatory cytokine levels Tear glucose levelsTimepoint: At 6 months | — |
Countries
India
Contacts
Public ContactSridevi Nair
Dr R P Centre for Ophthalmic Sciences, All Institute of Medical Sciences, Delhi
Outcome results
None listed