Improving Drop Instillation Comfort of a Cyclosporine A Solution

University of Waterloo

Status: Completed

Conditions: Dry Eye Disease

Treatments: Drug: 0.09% cyclosporine A ophthalmic solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05957211

45135

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

All participants

Experimental group

Description:

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.

Treatment:

Drug: 0.09% cyclosporine A ophthalmic solution