An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-da… (NCT03733899) | Clinical Trial Compass
CompletedNot Applicable
An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort
United Kingdom22 participantsStarted 2018-11-07
Plain-language summary
This is a controlled, randomized, subject-masked, 3x3 crossover, non-dispensing, contralateral study. Twenty subjects will be recruited based on their scores (with their habitual lenses) from the Contact Lens Dry Eye Questionnaire-8 and examined on four occasions.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. They are of legal age (18 years) and capacity of volunteer.
✓. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
✓. They must appear able and willing to adhere to the instructions set forth in this clinical protocol.
✓. They have worn the same brand of soft spherical contact lenses for at least the previous three months, by self-report.
✓. They are defined as 'symptomatic' contact lens wearers (CLDEQ-8 score of 20-37) with their habitual contact lenses.
✓. They are willing to wear their lenses for approximately 14 hours on study days.
✓. They have a wearable pair of spectacles, if applicable.
✓. They agree not to participate in other clinical research for the duration of this study.
Exclusion criteria
✕. They have an ocular disorder, which would normally contra-indicate contact lens wear.
✕. They have a systemic disorder, which would normally contra-indicate contact lens wear.
✕. They are using any topical medication such as eye drops or ointment.
✕. They have had cataract or corneal refractive surgery.
What they're measuring
1
Subjective Comfort Scores
Timeframe: 5 and 10 Minutes post-treament
2
Change in Subjective Comfort Scores From Pre-treatment to Post-treatment
Timeframe: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament
3
Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic
Timeframe: Immediately after lens-insertion, 5 and 10 minutes post-treatment