N/A N=30 Randomized Double-blind Treatment

Neurolens and Contact Lens Discomfort

Contact Lens Discomfort

Bottom Line

View on ClinicalTrials.gov: NCT05801991 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Change in Contact Lens Discomfort — -4.94; -8.67 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Neurolens (Device); Placebo spectacle lens (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Contact Lens Discomfort	-4.94; -8.67	—
SECONDARY Change in Convergence Insufficiency Symptoms	-8.86; -8.93	—
SECONDARY Change in Headache Symptoms	-3.14; -9.73	—
SECONDARY Change in Dry Eye Symptoms	-4.29; -6.67	—

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.

Eligibility Criteria

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) 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, and/or coverage
Significant lens deposits
Signs of corneal or conjunctival contact-lens related complications

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05801991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.