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OpenTrials
Completed

NCT Number: NCT05957211

Improving Drop Instillation Comfort of a Cyclosporine A Solution

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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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo

Waterloo, Ontario, N2J 3G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Cequa

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).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Sun Pharmaceutical Industries Limited

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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