Improving Drop Instillation Comfort of a Cyclosporine A Solution

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Waterloo
• Collaborator: Sun Pharmaceutical Industries Limited
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions

Criteria

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.