Improving Drop Instillation Comfort of a Cyclosporine A Solution

NCT05957211 | Completed

• 1 other identifier: 45135
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Keywords

dry eye disease; cyclosporine; eye drop

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All participants

EXPERIMENTAL

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

Interventions

0.09% cyclosporine A ophthalmic solution 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.

Also known as: Cequa

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age.
• Ocular Surface Disease Index score \>= 23.
• Strip meniscometry \< 5 mm.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead
• Sun Pharmaceutical Industries Limited: collaborator

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2J 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 24, 2023
• Study Start: May 19, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)