Neurolens and Contact Lens Discomfort

NCT05801991 | Completed Results FDA Device

• 1 other identifier: SCCOCLNeurolens
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contact Lens Discomfort

Outcome Measures

Primary Outcomes (1)

• Change in Contact Lens Discomfort

  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

  Baseline and 30-35 days

Secondary Outcomes (3)

• Change in Convergence Insufficiency Symptoms

  Baseline and 30-35 days

• Change in Headache Symptoms

  Baseline and 30-35 days

• Change in Dry Eye Symptoms

  Baseline and 30-35 days

Study Arms (2)

Neurolens Treatment

EXPERIMENTAL

Participants will receive Neurolens lenses (measured with the Neurolens device while wearing their habitual contact lenses) in their study spectacles

Device: Neurolens

Placebo Lens

PLACEBO COMPARATOR

Participants will receive plano (no power) lenses in their study spectacles

Device: Placebo spectacle lens

Interventions

Neurolens DEVICE

neurolens® is a type of spectacle lens that uses contoured prism to alleviate vergence demands and fatigue at near and, therefore, encourages comfortable vision.8 This spectacle design uses the neurolens® Measurement Device (nMD) to measure eye alignment and determine the spectacle lenses that are uniquely designed for each wearer.

Neurolens Treatment

Placebo spectacle lens DEVICE

Plano (no power) spectacle lenses will be assigned to the placebo group

Placebo Lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead
• Neurolens Inc.: collaborator

Study Sites (1)

The Southern California College of Optometry at Marshall B. Ketchum University

Fullerton, California, 92831, United States

Location

Results Point of Contact

• Title: Erin Rueff, OD, PhD (Principal Investigator)
• Organization: Southern California College of Optometry

erueff@ketchum.edu

714-463-7586

Study Officials

• Erin Rueff, OD, PhD

  Marshall B. Ketchum University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: May 1, 2023
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)