Neurolens and Contact Lens Discomfort
Phase: NA
Conditions: Contact Lens Discomfort
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University

PROTOCOL & CLINICAL TRIAL OUTLINE: Neurolens and Contact Lens Discomfort 
NCT05801991 
Principal Investigator: Erin Rueff, OD, PhD 
Document Date: 3/10/2025 
 
 
 
Study Title: Neurolens and Contact Lens Discomfort 
Study Site: The Southern California College of Optometry at Marshall B. Ketchum University 
                     Ketchum Health: 5460 E La Palma Ave, Anaheim, CA 92807 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL & CLINICAL TRIAL OUTLINE: Neurolens and Contact Lens Discomfort 
NCT05801991 
Principal Investigator: Erin Rueff, OD, PhD 
Document Date: 3/10/2025 
 
 
 
Background & Rationale 
Discomfort is the primary reason for contact lens dissatisfaction and discontinuation.1-3 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.4, 5 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.6 Eyestrain, fatigue, and increased/more frequent end-
of-day symptoms are noted by patients in both groups of conditions.6 It has been reported that 
uncomfortable contact lens wearers have an unusually high prevalence of binocular vision disorders and 
clinical signs.6 Basic optical calculations show that myopes must converge and accommodate more when 
corrected with contact lenses versus spectacles,7 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.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.8 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. 
Objective & Hypothesis 
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.  
Study Design 
A prospective, randomized clinical trial will be performed. Participants and investigators will be masked 
to the treatment. 
Sample Size 
This is the first study to explore the relationship between contact lens discomfort and neurolens® 
correction. The nature of this study is, therefore, exploratory and the data and results collected will be 
pilot in nature. A reasonable sample size goal has been determined to be 30-60 total participants (15-30 
per treatment group). 
 

PROTOCOL & CLINICAL TRIAL OUTLINE: Neurolens and Contact Lens Discomfort 
NCT05801991 
Principal Investigator: Erin Rueff, OD, PhD 
Document Date: 3/10/2025 
 
 
 
Primary Outcome Variable 
The primary outcome variable will be change in contact lens discomfort, as measured by the Contact Lens 
Dry Eye Questionnaire-8 (CLDEQ-8).9, 10 
Secondary Outcome Variables: 
Secondary outcome variables will be change in symptoms scores measured on the Convergence 
Insufficiency Treatment Trial (CISS), Headache Impact Test (HIT-6), and the Standard Patient Evaluation of 
Eye Dryness (SPEED).11-13 
Inclusion Criteria & Study Procedures: 
Table 1 lists all study inclusion and exclusion criteria. Figure 1 outlines the general flow of the study design.  
Study Materials 
The neurolens® Measurement Device (nMD2; neurolens, Inc. Costa Mesa, CA) and the neurolens spectacle 
lenses are Class 1 Medical Devices (exempt).   
The nMD2 is a desktop diagnostic instrument. The following is the description provided in the 
manufacturer’s nMD2 Users Manual:  
The nMD2 is a microprocessor-controlled system used to measure eye misalignment at distance 
and near. Eye misalignment is measured through a dissociative test where the eyes are shown 
independent non-fusible targets, and direction of gaze is measured. This measurement is 
combined with an associative test where peripheral fusion is attained, and central alignment is 
measured. Effectively this measurement of eye alignment is an objective measurement of the 
angle of strabismus, and/or an evaluation of binocular vision. 
The nMD2 uses an eye tracking system along with a stereoscopic display to measure eye 
alignment at distance and at near. From this information, a nMD2 number is calculated which is 
to be used along with other clinical assessments in the diagnosis and management of visual 
disorders. 
The neurolens spectacle lenses include a proprietary contour prism design that provides the patient with 
increasing prism from the distance to near portion of the lens. The prism value used in this study will be 
determined using the nMD2 device. No significant adverse events/risks are anticipated for any participant 
who is examined with the nMD2 device. 
All other study materials and instrumentation are those that are used in a normal eye examination, 
including anterior segment slit lamp assessment with sodium fluorescein staining and Schirmer tear 
volume assessment.  No significant adverse events/risks are anticipated for any participant who 
participates in the study and/or undergoes any study procedures. 
 
 

PROTOCOL & CLINICAL TRIAL OUTLINE: Neurolens and Contact Lens Discomfort 
NCT05801991 
Principal Investigator: Erin Rueff, OD, PhD 
Document Date: 3/10/2025 
 
 
 
Table 1: Inclusion/Exclusion criteria 
• 
Uncomfortable soft contact lens wearers (CLDEQ-8 ≥ 17 points)10 
• 
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 staining14 
*Schirmer score ≥ 7 mm15 
*Tear break-up time ≥ 7 seconds15 
• 
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 
 
 
 
 
 
 
 
 
 

PROTOCOL & CLINICAL TRIAL OUTLINE: Neurolens and Contact Lens Discomfort 
NCT05801991 
Principal Investigator: Erin Rueff, OD, PhD 
Document Date: 3/10/2025 
 
 
 
Participant Screening 
Potential participants in the MBKU community will be contacted via email and print advertisements. 
Participants will contact an investigator by phone, email, or QR code (contact information will be included 
in the email/flyer) to determine if they may qualify based on  basic inclusion criteria including the CLDEQ-
8 survey. The intended population that will be recruited are members of the MBKU community (students, 
faculty, staff) via MBKU email addresses (anyone with  email address). Please see the Protocol for more 
details on recruitment. Interested participants will be instructed via printed and emailed advertisements 
to contact study coordinators via email, phone, and/or QR code as described below:  
 
If potential participants contact study coordinators by email, study coordinators will call the interested 
participant and perform screening over the phone. The CLDEQ-8 will be administered verbally to 
determine initial eligibility, and then all other inclusion criteria that can be verified verbally will be 
confirmed over the phone. If the participant meets this inclusion criteria screening, they will be invited 
for a baseline examination.  
If potential participants contact study coordinators over the phone, The CLDEQ-8 will be administered 
verbally to determine initial eligibility, and then all other inclusion criteria that can be verified verbally will 
be confirmed over the phone. If the participant meets this inclusion criteria screening, they will be invited 
for a baseline examination. 
If potential participants utilize the QR code included on the advertisement, the QR code will lead them to 
an online version of the CLDEQ-8 that the potential participant will complete. If their score qualifies them 
for the study, they will be instructed to contact study coordinators via phone or email. The study 
coordinators will then complete screening as described above. 
The score obtained on the pre-screening CLDEQ-8 will not be used in the study. 
Baseline Examination, Participant Enrollment, & Randomization 
The baseline and enrollment examination is expected to last approximately one hour. At the baseline 
examination, all inclusion criteria will be confirmed again. Informed consent and HIPAA forms will be 
distributed to and signed by each participant. Participants will be asked to bring a copy of their current 
contact lens prescription and/or the boxes/blister packages of their current contact lenses to confirm 
prescription information.  
Visual acuity will be measured monocularly with the habitual soft contact lenses at distance 
(approximately 6 meters) with a high contrast Snellen chart. Subjective over-refraction will be performed 
using a phoropter. These measurements will not influence eligibility for study inclusion. The CLDEQ-8, 
CISS, HIT-6, and SPEED questionnaires will be administered on an iPad. 
The fit of the habitual soft contact lenses will be assessed with a slit lamp. The lenses will be removed and 
the patients will wait approximately ten minutes to allow the tear film to equilibrate. The neurolens® 
Measurement Device will then be used to obtain objective binocular vision measurements while the 
contact lenses have been removed, the tear film has equilibrated, and before topical fluorescein has been 
instilled. Topical fluorescein will be instilled to measure ocular surface staining and tear break-up time. 
General corneal, conjunctival, and anterior segment health will be assessed in the slit lamp. Schirmer 

PROTOCOL & CLINICAL TRIAL OUTLINE: Neurolens and Contact Lens Discomfort 
NCT05801991 
Principal Investigator: Erin Rueff, OD, PhD 
Document Date: 3/10/2025 
 
 
 
strips will be instilled in the lower temporal canthus of the right eye for five minutes to determine Schirmer 
score. 
Once all inclusion criteria have been confirmed, participants will be enrolled and assigned to a treatment 
group. Participants who do not meet all inclusion criteria will be excused from the study and compensated 
for their time ($50). Participants who meet all inclusion criteria will be informed that they will receive 
their study compensation ($100) upon completion of the study at the final visit.  
Randomization to treatment group will be achieved using an online random number generator to 
determine the order of allocation (1:1) before subject enrollment. Participants will be enrolled and 
assigned to a treatment group in the order they qualify for enrollment at the baseline examination. 
Enrolled participants will be provided with a $100 credit card cash gift card to offset the cost of spectacle 
frames that can be purchased at the Ketchum Health University Eye Center Optical, or they can provide 
their own spectacle frame. Once a frame has been identified, it will be sent to the neurolens® lab for 
fabrication and placement of lenses depending on treatment group assignment. Participants in the 
placebo group will receive single vision plano lenses. Participants in the neurolens® group will receive 
lenses based on the measurements made by the neurolens® Measurement Device.  
Participants will be contacted when their completed spectacles have arrived. At pick-up, each participant 
will be instructed to wear the spectacles full time over their habitual contact lenses. At this time, they will 
schedule the final study visit 35 ± 5 days after spectacle pick-up. 
Final Examination 
The final examination is anticipated to last approximately 30 minutes. At the final examination, 
participants will be instructed to return wearing their habitual soft contact lenses and the spectacles 
dispensed at the last visit. Visual acuity will be measured monocularly with the habitual soft contact lenses 
and study spectacles at distance (approximately 6 meters) with a high contrast Snellen chart. The 
spectacles will be removed and repeat measurements will be taken using the neurolens® Measurement 
Device. Participants will complete the CLDEQ-8, CISS, HIT-6 and SPEED surveys. Participants will be asked 
to report approximately how many hours per day and days per week they wore their contact lenses, and 
the same parameters for their time wearing the contact lenses with the study spectacles over the last 35 
± 5 days. 
After all measurements and surveys have been completed for all subjects, participants will be unmasked 
to the treatment group they are in. Both groups will be able to keep the spectacle lenses dispensed in the 
study, will be compensated for their time at both visits ($100), and will be dismissed from the study. 

PROTOCOL & CLINICAL TRIAL OUTLINE: Neurolens and Contact Lens Discomfort 
NCT05801991 
Principal Investigator: Erin Rueff, OD, PhD 
Document Date: 3/10/2025 
 
 
 
 
Figure 1: Flow chart of study procedures 
Informed Consent and Patient Privacy 
Upon arriving at the baseline examination visit, all participants will sign an informed consent form. The 
form will explain the purpose of the study, any anticipated risks/benefits, and the rights the participant 
has. Each participant will be able to ask investigators questions and keep a copy of the informed consent 
form. As well, all participants will sign a Health Insurance Portability and Accountability Act (HIPAA) 
explaining that their health information is private and any personal health identifiers collected in the study 
will not be used in association with their identity and/or for any other purpose. Additionally, all 
participants will read and sign the MBKU COVID research consent document. 
Statistical Analyses 
Statistical analyses will be performed to compare the survey scores of the two treatment groups before 
and after treatment. ANOVA and/or Wilcoxon Rank testing will be used depending on the distribution of 
the data according to Shapiro statistics. Additional analyses will also be performed to determine if 
particular demographic information (gender, age, etc.) and/or clinical data (refractive error, wear time, 
etc.) influenced symptom changes as measured by the four surveys administered. 
 
Treatment Group: 
Neurolens  
Placebo Group: 
Placebo 
Phone Screening to Determine Initial Eligibility 
Baseline Examination, Enrollment, & Randomization 
Spectacle Pick-Up 
Final Examination  
35 ± 5 days 

PROTOCOL & CLINICAL TRIAL OUTLINE: Neurolens and Contact Lens Discomfort 
NCT05801991 
Principal Investigator: Erin Rueff, OD, PhD 
Document Date: 3/10/2025 
 
 
 
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