An interventional study of Neurolens and Placebo spectacle lens in Contact Lens Discomfort, sponsored by Southern California College of Optometry at Marshall B. Ketchum University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by Southern California College of Optometry at Marshall B. Ketchum University · Not applicable, Interventional, and Treatment
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.
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.
Southern California College of Optometry at Marshall B. Ketchum University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Soft, spherical or low toric, single vision soft contact lens wearer:
No significant subjective over-refraction in either eye with habitual soft contact lenses
Valid measurement on the neurolens® Measurement Device (nMD2)
Exclusion Criteria:
Significant signs of dry eye:
Signs of inappropriate fit or surface of soft contact lenses
Participants will receive Neurolens lenses (measured with the Neurolens device while wearing their habitual contact lenses) in their study spectacles
Device: Neurolens
Participants will receive plano (no power) lenses in their study spectacles
Device: Placebo spectacle lens
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.
Plano (no power) spectacle lenses will be assigned to the placebo group
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
Time frame: Baseline and 30-35 days
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
Time frame: 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
Time frame: 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
Time frame: Baseline and 30-35 days
| Milestone | Neurolens Treatment | Placebo Lens |
|---|---|---|
| Started | 15 | 15 |
| Completed | 14 | 15 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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
| Scores on a scale | Neurolens Treatment | Placebo Lens |
|---|---|---|
| Change in Contact Lens Discomfort | -4.94 ± 3.84 | -8.67 ± 5.03 |
Change in convergence insufficiency symptoms measured by the Convergence Insufficiency Symptom Survey (CISS), Score range 0 - 60 points, Higher scores indicate worse symptoms
| Scores on a scale | Neurolens Treatment | Placebo Lens |
|---|---|---|
| Change in Convergence Insufficiency Symptoms | -8.86 ± 7.63 | -8.93 ± 9.58 |
Change in headache symptoms measured by the Headache Impact Test (HIT-6), Score range: 36 - 78 points, Higher scores indicate worse symptoms
| Scores on a scale | Neurolens Treatment | Placebo Lens |
|---|---|---|
| Change in Headache Symptoms | -3.14 ± 9.69 | -9.73 ± 9.63 |
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
| Scores on a scale | Neurolens Treatment | Placebo Lens |
|---|---|---|
| Change in Dry Eye Symptoms | -4.29 ± 4.30 | -6.67 ± 4.47 |
Collected over Baseline and 30-35 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neurolens Treatment | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Placebo Lens | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Neurolens Treatment | Placebo Lens | Total |
|---|---|---|---|
| Mean | 24.57 ± 2.14 | 26.20 ± 3.26 | 25.41 ± 2.85 |
| Sex/Gender, Customized(Participants) | Neurolens Treatment | Placebo Lens | Total |
|---|---|---|---|
| Gender — Male | 10 | 13 | 23 |
| Gender — Female | 2 | 2 | 4 |
| Gender — Chose not to declare | 2 | 0 | 2 |
| Race and Ethnicity Not Collected(Participants) | Neurolens Treatment | Placebo Lens | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Neurolens Treatment | Placebo Lens | Total |
|---|---|---|---|
| United States | 14 | 15 | 29 |
| Mean Contact Lens Wear Time (hours/day)(hours/day) | Neurolens Treatment | Placebo Lens | Total |
|---|---|---|---|
| Mean | 10.79 ± 3.58 | 10.80 ± 3.63 | 10.79 ± 3.48 |
| Mean Contact Lens Wear Time (days/week)(days/week) | Neurolens Treatment | Placebo Lens | Total |
|---|---|---|---|
| Mean | 5.79 ± 1.25 | 5.53 ± 1.46 | 5.66 ± 1.32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to make IPD available to other researchers at this time.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Southern California College of Optometry at Marshall B. Ketchum University