NCT05801991

Neurolens and Contact Lens Discomfort

Completed NA Results posted Last updated 22 April 2025

What this trial tests

NA trial testing Neurolens in Contact Lens Discomfort in 30 participants. Completed in 5 March 2024.

Timeline

1 May 2023

Primary endpoint
5 March 2024

5 March 2024

Quick facts

Lead sponsor	Southern California College of Optometry at Marshall B. Ketchum University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 May 2023
Primary completion	5 March 2024
Estimated completion	5 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Neurolens
• Placebo spectacle lens

Conditions studied

• Contact Lens Discomfort — all drugs for Contact Lens Discomfort →

Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Who can join

18 and older, any sex, with Contact Lens Discomfort. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Contact Lens Discomfort Primary · Baseline and 30-35 days

Change in contact lens discomfort measured by the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8), Score range: 0 - 37 points, Higher scores indicate worse symptoms

Group	Value	95% CI
Neurolens Treatment	-4.94	± 3.84
Placebo Lens	-8.67	± 5.03

Change in Convergence Insufficiency Symptoms Secondary · Baseline and 30-35 days

Change in convergence insufficiency symptoms measured by the Convergence Insufficiency Symptom Survey (CISS), Score range 0 - 60 points, Higher scores indicate worse symptoms

Group	Value	95% CI
Neurolens Treatment	-8.86	± 7.63
Placebo Lens	-8.93	± 9.58

Change in Headache Symptoms Secondary · Baseline and 30-35 days

Change in headache symptoms measured by the Headache Impact Test (HIT-6), Score range: 36 - 78 points, Higher scores indicate worse symptoms

Group	Value	95% CI
Neurolens Treatment	-3.14	± 9.69
Placebo Lens	-9.73	± 9.63

Change in Dry Eye Symptoms Secondary · Baseline and 30-35 days

Change in dry eye symptoms measured by the Standard Patient Evaluation of Eye Dryness (SPEED) survey, Score range: 0 - 28 points, Higher scores indicated worse symptoms

Group	Value	95% CI
Neurolens Treatment	-4.29	± 4.30
Placebo Lens	-6.67	± 4.47

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.