Neurolens and Contact Lens Discomfort (NCT05801991) | Clinical Trial Compass
CompletedNot Applicable
Neurolens and Contact Lens Discomfort
United States30 participantsStarted 2023-05-01
Plain-language summary
The objective of this study is to determine how neurolens® influences contact lens discomfort in uncomfortable myopic soft contact lenses wearers. It is hypothesized that uncomfortable soft contact lens wearers are experiencing some level of discomfort associated with increased vergence demand when looking at near targets and will experience discomfort relief when wearing neurolens® over their habitual soft contact lenses. Uncomfortable, myopic soft contact lens wearers will be recruited. Each participant will be masked and randomly assigned a placebo pair of spectacles or a neurolens® spectacle pair for approximately one month. A prospective, randomized clinical trial will be performed. Participants and investigators will be masked to the treatment.
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:
* Uncomfortable soft contact lens wearers (CLDEQ-8 ≥ 17 points)
* Adult, pre-presbyopic age range (18 - 35 years)
* Visual acuity of 20/25 or better in each eye with habitual contact lenses
* Soft, spherical or low toric, single vision soft contact lens wearer:
* Habitual contact lens sphere power -0.75 D or more myopic
* Habitual contact lens are spherical design or have 1.75 D or less of cylinder correction
* Habitual soft contact lenses are single vision design
* Valid contact lens prescription at the date of the baseline
* No significant subjective over-refraction in either eye with habitual soft contact lenses
* No significant subjective over-refraction in either eye with habitual soft contact lenses
* Sphere: ≤ 0.50 D myopia, ≤ 0.50 D hyperopia
* Cylinder: ≤ 0.75 D
* Valid measurement on the neurolens® Measurement Device (nMD2)
* A numerical neurolens value
* No low Measurement Quality Index (MQI) \< 0.8 or convergence excess
Exclusion Criteria:
* History of ocular surgery
* History of ocular disease, amblyopia, strabismus, or vision therapy
* History of neurolens or prism spectacle correction
* History of significant vertical phoria or vertical phoria correction
* Current ocular medication use
* Significant signs of dry eye:
* \> Grad 1 ocular surface staining
* Schirmer scores \< 7 mm
* Tear break up time \< 7 seconds
* Signs of inappropriate fit or surface of soft contact lenses
* Insufficient movement centration,…
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
Change in Contact Lens Discomfort
Timeframe: Baseline and 30-35 days
Trial details
NCT IDNCT05801991
SponsorSouthern California College of Optometry at Marshall B. Ketchum University