Improving Drop Instillation Comfort of a Cyclosporine A Solution

Sponsor

University of Waterloo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05957211

Collaborator

Sun Pharmaceutical Industries Limited (Industry)

Enrollment

Location

Arm

3.4

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: 0.09% cyclosporine A ophthalmic solution	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Improving Drop Instillation Comfort of a Cyclosporine A Solution

Actual Study Start Date :

May 19, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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. Other Names: Cequa

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Other Names:

Cequa

Outcome Measures

Primary Outcome Measures

Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort). [Within 10 minutes of drop instillation]
Difference in ocular discomfort between the eye that receives a refrigerated Cequa drop and the eye that receives a non-refrigerated (room temperature) drop.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.