Improving Drop Instillation Comfort of a Cyclosporine A Solution

Patients who suffer from dry eye disease are often prescribed eye drops containing cyclosporine A that help with reducing inflammation. The newest eye drop containing cyclosporine A is called Cequa (Sun Pharma, Canada). Unfortunately, nearly a quarter of (24.2%) of patients using Cequa have reported some form of discomfort (burning and stinging) when instilling the drops. This potentially discourages patients from continuing the eye drop, which prevents their dry eye disease from being managed effectively. This study is trying to determine if refrigerating the eye drops would allow the drops to feel more comfortable when they are instilled in the eye.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: 0.09% cyclosporine A ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2J 3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years of age.
• Ocular Surface Disease Index score >= 23.
• Strip meniscometry < 5 mm.

Exclusion Criteria:

• Contact lens wearers.
• Have corneal neuropathic or neurotrophic disease.
• Have an ocular or medical condition or taking medications that could confound a study outcome.
• Currently pregnant or breastfeeding (cyclosporine is a FDA pregnancy Category C drug).
• Have an ocular or medical condition for which Cequa is contraindicated (e.g., allergy to cyclosporine or other ingredients in Cequacurrent eye infection, cancer or precancerous condition in or around the eyes).
• Have an allergy to fluorescein.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• 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: All participants; All participants will have a refrigerated 0.09% cyclosporine drop instilled in one eye, and a non-refrigerated 0.09% cyclosporine drop instilled in the other eye. The eye that receives the refrigerated drop is randomly determined.	Drug: 0.09% cyclosporine A ophthalmic solution; Cequa is an ophthalmic solution used to treat moderate to severe dry eye disease. The typical dosage is one drop in each eye, twice a day. The drug is packaged in sterile, single use bottles.; Other Names: Cequa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort).	Difference in ocular discomfort between the eye that receives a refrigerated Cequa drop and the eye that receives a non-refrigerated (room temperature) drop.	Within 10 minutes of drop instillation

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: cyclosporine; dry eye disease; eye drop
• 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: 45135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No