Health Condition 1: H041- Other disorders of lacrimal gland
Conditions
Interventions
Intervention1: Test: Cyclosporine 0.09% w/v Ophthalmic Solution: One drop of the test drug should be instilled into each eye twice daily approximately 12 hours apart for 12 weeks.
Control Intervention
Sponsors
Sun Pharma Laboratories Limited SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male, and non-pregnant, non-lactating female patients of age = 18 years who agree to provide written informed consent. 2) Patients with history of keratoconjunctivitis sicca (KCS) for a period of at least 6 months 3) Patients with clinical diagnosis of bilateral KCS. 4) Patients with Lissamine green conjunctival staining score of = 3 to = 9. 5) Patients with reported dry eye symptoms within 3 months prior to study. 6) Patients with corrected Snellen visual acuity (VA) of better than 20/200 in each eye 7) Willing to discontinue use of current therapy for KCS. 8) Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication. 9) Male patients must have had a successful vasectomy or they and their female partners must meet the criteria above. No sperm donation is allowed during the study period.
Exclusion criteria
Exclusion criteria: 1)Patients using cyclosporine ophthalmic preparations within 3 months prior to the Screening Visit. 2)Patients with history of previous treatment failure with cyclosporine ophthalmic solutions. 3)Patients with diagnosis of Sjogrens disease more than 5 years prior to the Screening visit. 4)Patients with clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis. 5)Patients using the following systemic or topical medications within 7 days prior to the Screening Visit or intended to use during the study period such as Immunomodulators, Systemic corticosteroids, Antihistamines, Cholinergics, Antimuscarinics, Tricyclic antidepressants, Phenothiazines, and Retinoids. 6)Patients using any topical ophthalmic medications, prescription or over the counter, other than the assigned study medication during the study period. 7)Patients on oral omega-3 fatty acids. 8)Patients with unstable macular disease. 9)Diagnosis of chronic uveitis or any chronic or potentially recurrent ocular condition. 10)Patients with current active eye disease other than KCS (i.e., any disease for which topical or systemic ophthalmic medication is necessary). 11)Patients with any ocular disorder including ocular injury, infection, non-dry eye ocular inflammation, trauma, or surgery within the prior 6 months. 12)Patients with history of herpes keratitis. 13)Patients with history of corneal transplant. 14)Patients with history of corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved. 15)Patients who require surgical correction of dry eyes, and Contact lens wearers. 16)Patients with history of cataract surgery within 3 months prior to the Screening Visit. 17)Patients who have undergone non-laser glaucoma surgery at any time; or glaucoma laser procedures within 3 months prior to the Screening Visit. 18)Patients with lagophthalmos or clinically significant eyelid margin irregularity of either eye whether congenital or acquired. 19)Patients with history of any cancer within 5 years of screening. 20)Patients who have plans to undergo major elective surgery during the course of the study. 21)Patients with history of or currently having any of the severe/serious ocular condition or clinically significant medical conditions, such as cardiovascular, respiratory, renal, hepatic, endocrine, or gastrointestinal disease. 22)Patients with history of or known case of HIV-AIDS, hepatitis B, and hepatitis C. 23)Patients with history of hypersensitivity or allergic reaction study medication or its component(s). 24)Participation in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months. 25)Investigator, study personnel, Sponsor representatives and their first degree relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Proportion of patients with treatment-emergent adverse events (TEAEs)Timepoint: Day 1, Day 28, Day 56 & Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Proportion of patients with increase from baseline of =10 mm in Schirmers Test (Unanesthetized) Score based on data for both eyes Timepoint: Day 28, 56 & 84;Efficacy: Change from baseline in Schirmer’s Test (Unanesthetized) Score based on data for both eyesTimepoint: Day 28, 56 & 84;Efficacy: Change from baseline in Conjuctival (Lissamine green) staining score based on data for both eyesTimepoint: Day 28, 56 & 84;Efficacy: Change from baseline in Corneal fluorescein staining score based on data for both eyesTimepoint: Day 28, 56 & 84;Efficacy: Change from baseline in dry eye symptoms using SPEED Questionnaire scoreTimepoint: Days 28, 56 & 84 | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Limited
Outcome results
None listed