Improving Drop Instillation Comfort of a Cyclosporine A Solution

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: 0.09% cyclosporine A ophthalmic solution

• Registration Number: NCT05957211
• Lead Sponsor: University of Waterloo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-19
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-24
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	0.09% cyclosporine A ophthalmic solution	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada