Improving Drop Instillation Comfort of a Cyclosporine A Solution

Study Overview
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Brief Summary
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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.

Official Title
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Improving Drop Instillation Comfort of a Cyclosporine A Solution

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: 0.09% cyclosporine A ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>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<br>* 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.<br>* Other names: Cequa;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eye drop, dry eye disease, cyclosporine