Health Condition 1: null- Moderate to severe Dry Eye Disease
Conditions
Interventions
Intervention1: Cyclosporine: Cyclosporine ophthalmic microemulsion 0.05% one drop in both eyes to be administered twice daily
Control Intervention1: NIL: NIL
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Schirmers tear test scoreTimepoint: At week 4 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically significant changes in the ocular examinationTimepoint: During the study period;Global evaluation of overall effect of study medicationTimepoint: At week 4 from baseline;Incidence and nature of adverse eventsTimepoint: During the study period;Incidence of drug related adverse eventsTimepoint: During the study period;Mean change in Ocular discomfortTimepoint: At week 2 and week 4 from baseline;Mean change in Ocular Surface Disease Index ScoreTimepoint: At week 2 and week 4 from baseline;Use of artificial tearsTimepoint: At week 4 from baseline | — |
Countries
India
Contacts
Public ContactDr Nikhil Gokhale
Cipla Ltd.
Outcome results
None listed