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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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