TO COMPARE THE RESULTS OF USAGE OF TWO PREPARATION OF CYCLOSPORINE EYE DROPS 0.05% (AQUEOUS AND OIL BASED EYE DROPS) IN PATIENTS WITH DRY EYE SYNDROME.

Phase 3

• Conditions: Health Condition 1: H041- Other disorders of lacrimal gland

• Registration Number: CTRI/2021/11/038067
• Lead Sponsor: AIIMS NEW DELHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Aged 18 to 65 years old

2)Moderate to severe DED

3)Tear film break-up time (TBUT) <= 10seconds

4)Corneal fluorescein staining (fluorescein staining score of >3 out of 15 in either eye)

5)Schirmer I test <= 5mm/5min

6)OSDI score > 23

Exclusion Criteria

1)History of ocular trauma,active blepharitis, infection, or inflammation not associated with DED during the 3-month period preceding the screening visit

2)Patients with one blind eye

3)Patients with history of active stage of any other concomitant ocular disease

4)Ocular surgery within 3 months preceding the study

5)History of hypersensitivity or any medical condition that contraindicates the use of the study drug or any of its compounds, or derivatives

6)Patients taking any medication, topically or by any other route, which could interfere with the studyâ??s results, in the 3 days prior to trial, or until a time period in which residual effects could be present

7)Contact lens wearer

8)Fertile-age women with an inadequate birth-control method, as well as pregnant or breastfeeding women

9)Legally disqualified or mentally disabled patients who cannot sign an informed consent

10)Patients who cannot comply with medical appointments or with all protocol requirements

11)Patients who disagree to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the clinical outcome of aqueous based and oil based 0.05% cyclosporine eye drops in the treatment of moderate to severe dry eye disease. <br/ ><br>Timepoint: 3 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To compare the convenience and tolerability of aqueous based and oil based 0.05% cyclosporine eye drops in the treatment of moderate to severe dry eye disease.Timepoint: 3 months