Improving Drop Instillation Comfort of a Cyclosporine A Solution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2024-02-20

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.

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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All participants

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.

Group Type EXPERIMENTAL

0.09% cyclosporine A ophthalmic solution

Intervention Type DRUG

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.

Interventions

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0.09% cyclosporine A ophthalmic solution

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.

Intervention Type DRUG

Other Intervention Names

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Cequa

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No