This is a postmarketing surveillance to determine the efficacy and safety of 0.05 % Cyclosporine ophthalmic micro-emulsion for the treatment of Moderate to Severe Dry eye disease

Phase 4

Completed

• Conditions: Health Condition 1: null- Moderate to severe Dry Eye Disease

• Registration Number: CTRI/2010/091/000095
• Lead Sponsor: Cipla Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1.Subjects willing to give written informed consent.

2.Subjects of either sex of 18 years and above.

3.Ocular Surface Disease Index Score greater than or equal to 0.25, unless subject has Sjogren syndrome or thyroid autoimmune disease.

4.Schirmer?s test with anesthesia of less than 5 mm / 5 min.

5.Best corrected visual acuity greater than 6/24.

6.In the opinion of the investigator, able to comply with the requirements of the protocol.

Exclusion Criteria

1.Subjects with hypersensitivity to study drug or any exipients of its formulation.
2.Presence or history of any systemic or ocular disorder or condition including ocular surgery, trauma, or ocular disease that could interfere with interpretation of study results.
3.Current or recent use of topical ophthalmic or systemic medications that could affect dry eye condition.
4.Required contact lenses wear during study.
5.Current infections of the anterior segment or uveitis.
6.Any disease of the eye leading to diffuse loss of conjunctiva including ocular pemphigoid, chemical burns, steven Johnson syndrome and hypervitaminosis A.
7.Any active ocular diseases excluding glaucoma other than blepharitis.
8.Within one month or anticipated use of temporary punctual plugs during study or permanent occlusion of lacrimal puncta within 3 months.
9.Participated in an investigational study 30 days prior to screening visit.
10.Females who are pregnant, lactating or planning to become pregnant.
11.End stage Lacrimal gland disease (scheimer's reading with nasal stimulation of < 3 mm/5min) or if the dry eye disease is as a result of destruction of conjunctival goblet cells or scarring.
12.Judged by Investigator to be inappropriate as subjects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified