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

Brief Summary: This is a Phase- IV open label post marketing surveillance to determine the efficacy and safety of 0.05 % Cyclosporine ophthalmic micro-emulsion for the treatment of Moderate to Severe Dry eye disease. This study was conducted at four centres through out the India. This study consists of 4 weeks of treatment period. In this study Mean change in Schirmer's test score at week four from the baseline visit was determined as a primary endpoint. Mean change in Ocular Surface Disease Index Score, mean change in Ocular Discomfort, global evaluation of overall effect of study medication and use of artificial tears were determined as secondary endpoints. Incidence and nature of drug related adverse events, clinically significant changes in the ocular examination were assessed as a safety endpoints.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Mean change in Schirmers tear test score	At week 4 from baseline

Secondary Outcome Measures

Name	Time	Method
Mean change in Ocular Surface Disease Index Score	At week 2 and week 4 from baseline
Mean change in Ocular discomfort	At week 2 and week 4 from baseline
Global evaluation of overall effect of study medication	At week 4 from baseline
Use of artificial tears	At week 4 from baseline
Incidence and nature of adverse events	During the study period
Incidence of drug related adverse events	During the study period
Clinically significant changes in the ocular examination	During the study period

Locations (4): Cornea Foundation
🇮🇳
Ahmadabad, GUJARAT, India
Diva Eye Institute
🇮🇳
Ahmadabad, GUJARAT, India
Gokhale Eye Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
T C Eye Centre
🇮🇳
Lucknow, UTTAR PRADESH, India
Cornea Foundation
🇮🇳Ahmadabad, GUJARAT, India
Dr. Bharti C. Lavingia
Principal investigator
dr_bclavingia@hotmail.com