Health Condition 1: H048- Other disorders of lacrimal system
Conditions
Interventions
Intervention1: 0.05% Cyclosporine A + artificial tears (0.3% CMC): Participants will receive 0.05% Cyclosporine A. Additionally, patients from both the groups will receive artificial tear (0.3% CMC).
Sponsors
Dr Phulen Sarma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Total corneal fluorescein staining (CFS) score greater than or equal to 10 2. Dryness symptom score greater than or equal to 50 3. Total conjunctival staining score greater than or equal to 2 4. Schirmer I test score (without anaesthesia): between 1 mm and 10 mm at 5 minutes 5. Willing and able to comply with the study protocol and scheduled visits 6. Willing provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Active ocular infection or inflammation not related to dry eye 2. Ocular surgery or trauma within the past 3 months 3. Use of topical ocular anti-inflammatory medications (including steroids) within 30 days prior to screening 4. Known allergy or hypersensitivity to cyclosporine or any study medication components 5. Presence of systemic autoimmune diseases affecting the eyes 6. Pregnant or breastfeeding women 7. Clinically significant slit-lamp findings or abnormal lid anatomy at screening 8. Ocular/periocular malignancy 9. History of herpetic keratitis 10. Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study 11. Use of topical Cyclosporine A within 2 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the safety of 0.05% Cyclosporine A versus 0.1% among patients with moderate to sever dry eye. 2. To evaluate the change in Schirmer?s test values in both the groups. Timepoint: Baseline , 1.5 month, 3 month, 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| ? To assess the improvement in ocular symptoms (e.g., burning, dryness, foreign body sensation) after treatment with two different regimen of Cyclosporine A (0.05% vs. 0.1%) plus artificial tear. ? To assess changes in Tear Break-Up Time (TBUT) and corneal/conjunctival staining scores. Timepoint: Baseline, 1.5 month, 3 month, 6 month | — |
Countries
India
Contacts
Public ContactDr Phulen Sarma
AIIMS, Guwahati
Outcome results
None listed