Neurolens and Contact Lens Discomfort

The objective of this study is to determine how neurolens® influences contact lens discomfort in uncomfortable myopic soft contact lenses wearers. We hypothesize 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Contact Lens Discomfort
• Intervention / Treatment: Device: Neurolens; Device: Placebo spectacle lens

Detailed Description

Discomfort is the primary reason for contact lens dissatisfaction and discontinuation. Symptoms of contact lens discomfort are often attributed to dryness; however, severity of dry eye and discomfort symptoms is not correlated with clinical dry eye severity. When clinical signs of contact lens discomfort and dryness misalign with symptom severity, the possibility of an under-recognized etiology must be considered

. Symptoms associated with contact lens discomfort are similar to symptoms reported with binocular vision disorders and accommodative and vergence strain. Eyestrain, fatigue, and increased/more frequent end-of-day symptoms are noted by patients in both groups of conditions. It has been reported that uncomfortable contact lens wearers have an unusually high prevalence of binocular vision disorders and clinical signs. Basic optical calculations show that myopes must converge and accommodate more when corrected with contact lenses versus spectacles, so it is reasonable to hypothesize that a myopic contact lens wearer may experience eyestrain and discomfort associated with vergence fatigue while wearing contact lenses, but not while wearing single vision spectacles.

neurolens® is a type of spectacle lens that uses contoured prism to alleviate vergence demands and fatigue at near and, therefore, encourages comfortable vision. 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. Acknowledging that some amount of contact lens discomfort may be caused by vergence fatigue, it is possible that uncomfortable contact lens wearers who wear neurolens® over their contact lenses will achieve discomfort relief.

The objective of this study is to determine how neurolens® influences contact lens discomfort in uncomfortable myopic soft contact lenses wearers. We hypothesize 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Rueff, OD, PhD; Phone Number: 714-463-7586; Email: erueff@ketchum.edu
• Study Contact Backup: Name: Vivek Labhishetty, BSOpt, PhD; Email: vivek.labhishetty@neurolenses.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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, single vision soft contact lens wearer:

• Habitual contact lens sphere power -0.75 D or more myopic
• Habitual contact lens are spherical design
• 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

• Sphere: ≤ 0.50 D myopia, ≤ 0.50 D hyperopia
• Cylinder: ≤ 0.75 D

No history of ocular surgery

No history of ocular disease, amblyopia, strabismus, or vision therapy

No history of neurolens or prism spectacle correction

No history of significant vertical phoria or vertical phoria correction

No current ocular medication use

No significant signs of dry eye in any eye:

*≤ Grade 1 ocular surface staining

• Schirmer score ≥ 7 mm
• Tear break-up time ≥ 7 seconds

Appropriate fit and surface of habitual soft contact lenses:

• Sufficient movement, centration, and coverage
• No significant lens deposits
• No signs of corneal or conjunctival contact-lens related complications

Valid measurement on the neurolens® Measurement Device (nMD2)

• A numerical neurolens value
• Acceptable Measurement Quality Index (MQI)
• No low MQI (<0.8) or convergence excess

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurolens Treatment; Participants will receive Neurolens lenses (measured with the Neurolens device while wearing their habitual contact lenses) in their study spectacles	Device: Neurolens; 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.
Placebo Comparator: Placebo Lens; Participants will receive plano (no power) lenses in their study spectacles	Device: Placebo spectacle lens; Plano (no power) spectacle lenses will be assigned to the placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in contact lens discomfort	Change in contact lens discomfort measured by the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)	30-35 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in convergence insufficiency symptoms	Change in convergence insufficiency symptoms measured by the Convergence Insufficiency Symptom Survey (CISS)	30-35 days
Change in headache symptoms	Change in headache symptoms measured by the Headache Impact Test (HIT-6)	30-35 days
Change in dry eye symptoms	Change in dry eye symptoms measured by the Standard Patient Evaluation of Eye Dryness (SPEED) survey	30-35 days

Collaborators and Investigators

• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
• Collaborators: Neurolens Inc.
• Investigators: Principal Investigator: Erin Rueff, OD, PhD, Marshall B. Ketchum University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SCCOCLNeurolens

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available to other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes