Improving Drop Instillation Comfort of a Cyclosporine A Solution

Dry Eye Disease Clinical Trial

Official title:

Improving Drop Instillation Comfort of a Cyclosporine A Solution

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957211
• Other study ID #: 45135
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: July 2023
• Source: University of Waterloo
• Contact: William Ngo, OD PhD
• Phone: 519-888-4567
• Email: wngo[@]uwaterloo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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