Effect of Cequa™ in Subjects With Dry Eye Disease

Overview

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.

Full Title of Study: “Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 24, 2022

Detailed Description

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.

Interventions

  • Drug: CequaTM (Cyclosporine 0.09%) ophthalmic solution
    • One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.

Arms, Groups and Cohorts

  • Experimental: CequaTM (Cyclosporine 0.09%) ophthalmic solution

Clinical Trial Outcome Measures

Primary Measures

  • Mean Change in Baseline in Total Corneal Fluoroscein Staining Score
    • Time Frame: Week12
    • Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea
  • Change From Baseline in Modified Dry Eye Scoring.
    • Time Frame: Week12
    • 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.

Secondary Measures

  • Mean Change in Baseline for Conjunctival Staining Assessment
    • Time Frame: Week 12
    • Based on Investigator’s judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity. Scale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival
  • Changes From Baseline in Central Corneal Staining Score
    • Time Frame: Week 12
    • 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 NEI grading scale
  • Mean Change in Baseline for Tear Osmolarity Score for Both Eyes
    • Time Frame: Week 12
    • 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). Tear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively.
  • Mean Change From Baseline in Frequency of Artificial Tear Product Use.
    • Time Frame: Week 12
    • Based on entries in the subject diaries, frequency of artificial tear product use will be assessed. Frequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome
  • Schirmer’s Test Score
    • Time Frame: Week 12
    • An unanesthetized Schirmer’s test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production.
  • Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.
    • Time Frame: Week 12
    • Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment). Note- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment.

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months. 2. Aged of at least 18 years. 3. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale. 4. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale. 5. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit Exclusion Criteria:

1. Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit. 2. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion. 3. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye. 4. Subjects who had already Use initiated any systemic or topical ocular medication.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Pharmaceutical Industries Limited
  • Provider of Information About this Clinical Study
    • Sponsor

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