Contact Lens DiscomfortNCT05801991
Neurolens and Contact Lens Discomfort
A study testing Neurolens in people with Contact Lens Discomfort, run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Discomfort
- What is being tested?
- Neurolens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- > 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California, 92831
About this study
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.
Read the 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. Investigators 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.
- Conditions
- Contact Lens Discomfort
- Being tested
- Neurolens, Placebo spectacle lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurolensDevice
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 spectacle lensDevice
Plano (no power) spectacle lenses will be assigned to the placebo group
| Study group | Role | What they receive |
|---|---|---|
| Neurolens Treatment | Experimental | Participants will receive Neurolens lenses (measured with the Neurolens device while wearing their habitual contact lenses) in their study spectacles Receives: Device: Neurolens |
| Placebo Lens | Placebo comparator | Participants will receive plano (no power) lenses in their study spectacles Receives: Device: Placebo spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 30-35 days
Secondary outcomes (3)
Change in Convergence Insufficiency Symptoms
Change in convergence insufficiency symptoms measured by the Convergence Insufficiency Symptom Survey (CISS), Score range 0 - 60 points, Higher scores indicate worse symptoms
Measured: Baseline and 30-35 days
Change in Headache Symptoms
Change in headache symptoms measured by the Headache Impact Test (HIT-6), Score range: 36 - 78 points, Higher scores indicate worse symptoms
Measured: Baseline and 30-35 days
Change in Dry Eye Symptoms
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
Measured: Baseline and 30-35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 May 2023
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contact Lens DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Collaborators
- Neurolens Inc.
- Responsible party
- Sponsor
- Investigators
- Erin Rueff, OD, PhD, Principal investigator, Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801991
- Sponsor's protocol ID
- SCCOCLNeurolens
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2023
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make IPD available to other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurolens and Contact Lens Discomfort
- ClinicalTrials.gov ID
- NCT05801991
- Acronym / sponsor ID
- SCCOCLNeurolens
- Conditions
- Contact Lens Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Collaborators
- Neurolens Inc.
- Study start
- 1 May 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Posted 22 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Investigators 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurolens Treatment | Experimental | Device: NeurolensParticipants will receive Neurolens lenses (measured with the Neurolens device while wearing their habitual contact lenses) in their study spectacles |
| Placebo Lens | Placebo comparator | Device: Placebo spectacle lensParticipants will receive plano (no power) lenses in their study spectacles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- No significant subjective over-refraction in either eye with habitual soft contact lenses
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurolensneurolens® 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. | Device | Neurolens Treatment |
| Placebo spectacle lensPlano (no power) spectacle lenses will be assigned to the placebo group | Device | Placebo Lens |
Primary outcome
Change in Contact Lens Discomfort
Time frame: 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
3 secondary outcomes
Change in Convergence Insufficiency Symptoms
Time frame: Baseline and 30-35 days
Change in Headache Symptoms
Time frame: Baseline and 30-35 days
Change in Dry Eye Symptoms
Time frame: Baseline and 30-35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers at this time.
Related trials for Contact Lens Discomfort
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
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Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
Dry Eye, Contact Lens Discomfort
Recruiting
Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
Dry Eye
Active, not recruiting
Meibomian Gland Dysfunction Management
Contact Lens Discomfort, Meibomian Gland Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Rueff, OD, PhD principal investigator
Marshall B. Ketchum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurolens in people with Contact Lens Discomfort, run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Contact Lens Discomfort (time frame: Baseline and 30-35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.