Improving Drop Instillation Comfort of a Cyclosporine A Solution

Last updated: August 7, 2024
Sponsor: University of Waterloo
Overall Status: Completed

Phase

N/A

Condition

Dry Eyes

Eyelid Inflammation

Sjogren's Syndrome

Treatment

0.09% cyclosporine A ophthalmic solution

Clinical Study ID

NCT05957211
45135
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over 18 years of age.

  • Ocular Surface Disease Index score >= 23.

  • Strip meniscometry < 5 mm.

Exclusion

Exclusion Criteria:

  • Contact lens wearers.

  • Have corneal neuropathic or neurotrophic disease.

  • Have an ocular or medical condition or taking medications that could confound astudy outcome.

  • Currently pregnant or breastfeeding (cyclosporine is a FDA pregnancy Category Cdrug).

  • Have an ocular or medical condition for which Cequa is contraindicated (e.g.,allergy to cyclosporine or other ingredients in Cequacurrent eye infection, canceror precancerous condition in or around the eyes).

  • Have an allergy to fluorescein.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: 0.09% cyclosporine A ophthalmic solution
Phase:
Study Start date:
May 19, 2023
Estimated Completion Date:
February 20, 2024

Connect with a study center

  • University of Waterloo

    Waterloo, Ontario N2J 3G1
    Canada

    Site Not Available

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