Contact Lens, Contact Lens Discomfort, Contact Lens Dryness
Conditions
Keywords
Keratoconjunctivitis Sicca, Dry Eye Disease, Eye Dryness
Brief summary
The most common reason for contact lens discontinuation is contact lens discomfort. The investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. This study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.
Detailed description
Contact lens discontinuation is mostly associated with ocular discomfort. Most patients identifying dryness as the primary reason for contact lens discontinuation. Patients often resort to contact lens solutions, lubricating and/or rewetting drops to temporality improve their contact lens wearing experience. Clinicians often resort to changing contact lens designs, solutions and wearing modalities to improve comfort. Contact lens discomfort is believed to be mediated by many factors including inflammation and very similar in clinical symptoms of dry eye disease and symptoms of dryness. Lifitegrast 5.0% ophthalmic solution is an FDA approved solution for the management of signs and symptoms of dryness of dry eye disease. Studies have shown lifitegrast 5% ophthalmic solution may work by blocking the interaction between ICAM-1 and LFA-1 leading to a decrease in activation and recruitment of T-cells, an initial step in inflammation. The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients for signs (https://www.xiidra-ecp.com/efficacy-treating-signs) and symptoms (https://www.xiidra-ecp.com/efficacy-symptom-improvement). The purpose of this open label, interventional study is to examine the effect of lifitegrast 5% ophthalmic solution in contact lens wearing experience by using the CLDEQ-8.
Interventions
DRUGLifitegrast
Lifitegrast used twice a day
Sponsors
EV Clinical Trials
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Agree with study protocol 2. Provide Informed Consent 3. Age 21 or over 4. Previous 10 months history of self-assessed comfortable wear samfilcon A contact lenses
Exclusion criteria
1. Unable or unwilling to comply with study protocol 2. Unable of unwilling to provide Informed consent 3. Self-reported symptomatic intolerance of contact lenses 4. History of an active anterior segment, eyelids, eyelashes, corneal or conjunctival pathology, ongoing ocular infection, inflammation or any other ocular problem that would require management with additional topical ophthalmic medications. 5. Have had a history of corneal surgery (corneal transplants, LASIK, PRK). \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CLDEQ-8 scores as reported by study participants | baseline to week 8 | measured changes in CLDEQ-8 scores as reported by study participants |
| Lisamine (corneal, conjunctiva) staining scores | baseline to week 8 | Lisamine score using the Oxford-Schema scoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline to week 8 | Best corrected visual acuity measured by Snellen chart |
Countries
United States
Outcome results
None listed