Improving Drop Instillation Comfort of a Cyclosporine A Solution

University of Waterloo40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Dry Eye Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Within 10 minutes of drop instillation