Dry Eye Disease
Conditions
Keywords
dry eye disease, cyclosporine, eye drop
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.
Interventions
DRUG0.09% 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.
Sponsors
Sun Pharmaceutical Industries Limited
University of Waterloo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed