Effect of Cequa™ in Subjects With Dry Eye Disease

Study Overview
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Brief Summary
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This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.

Detailed Description
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This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.

Official Title
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Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: CequaTM (Cyclosporine 0.09%) ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months. Aged of at least 18 years. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit Exclusion Criteria: Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye. Subjects who had already Use initiated any systemic or topical ocular medication.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CequaTM (Cyclosporine 0.09%) ophthalmic solution<br> | Drug: CequaTM (Cyclosporine 0.09%) ophthalmic solution<br>* One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total corneal fluorescein staining score. | Five areas of the cornea will evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on symptoms. | Week12 | 
| Modified dry eye scoring. | Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms. | Week12 | 
| Co-primary endpoint: total corneal fluorescein staining score | Five areas of the cornea will evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on symptoms. | Week 12 | 
| Co-primary endpoint: modified symptom assessment in dry eye score | Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival staining assessment | Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity. | Week 12 | 
| Changes in central corneal staining score | Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on symptoms. | Week 12 | 
| Tear osmolarity score for both eyes | Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye). | Week 12 | 
| Frequency of artificial tear product use. | Based on entries in the subject diaries, frequency of artificial tear product use will be assessed. | Week 12 | 
| Schirmer's test score | Change in amount of wetting in mm and marked with a line on strip using schirmer's score. The smaller the amount of moisture on the paper, the fewer tears that person has produced. | Week 12 | 
| Percentage of subjects who prefer study treatments over prior treatment. | Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment). | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratoconjunctivitis Sicca, KCS, Dry eye