TO study the Safety and efficacy of Cyclisis PF eye drop for treatment of Dry Eye Disease.

Phase 3

• Conditions: Health Condition 1: H041- Other disorders of lacrimal glandHealth Condition 2: H048- Other disorders of lacrimal system

• Registration Number: CTRI/2024/05/068159
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Subjects between 18-75 years of age of both genders

2.Subjects with known case of dry eye disease

3.Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better

4.Ocular Surface Disease Index (OSDI) = 18

5.Tear film break-up time (TBUT) = 10 seconds

6.Schirmer tear test (without anesthesia) = 10mm / 5min

7.Tear Meniscus Height < 0.25mm

8.Corneal fluorescein staining score [as per National Eye Institute (NEI) scale] = 3

9.Conjunctival lissamine green staining score (as per NEI scale) =6

10.Normal lid position and closure

11.Willingness to sign written informed consent document

Exclusion Criteria

1. Any ocular condition that, in the opinion of the Investigator, could affect study parameters. This includes, active ocular infection, ocular inflammation, ocular trauma, blepharitis or, any other condition as deemed by the Investigator.

2.Unwilling to refrain from contact lens use for the entire duration of this study.

3.Any significant illness that could interfere with study parameters.

4.History of any other ocular surgical procedure within 3 months.

5.Subject with known allergy or hypersensitivity to the components of the formulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified