Effect of Cequa™ in Subjects With Dry Eye Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: CequaTM (Cyclosporine 0.09%) ophthalmic solution

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers, 4225 Evans Ave.
    • Jacksonville, Florida, United States, 32256
      • Bowden Eye and Associates, 7205 Bonneval Road
    • Panama City, Florida, United States, 32405
      • Eye Center of N Florida, 2500 Martin Luther King Jr Blvd
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care, 2521 N Broadway
  • Texas
    • Hurst, Texas, United States, 76054
      • Texas Eye and Laser Center, 1872 Norwood Dr. #200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Baseline in Total Corneal Fluoroscein Staining Score	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	Week12
Change From Baseline in 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Baseline for Conjunctival Staining Assessment	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	Week 12
Changes From Baseline 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 NEI grading scale	Week 12
Mean Change in Baseline for 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). 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.	Week 12
Mean Change From Baseline in Frequency of Artificial Tear Product Use.	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	Week 12
Schirmer's Test Score	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.	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). Note- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment.	Week 12

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): June 24, 2022

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dry eye; Keratoconjunctivitis Sicca; KCS
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: OTX101-2019-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No