Contact Lens Discomfort
Conditions
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.
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.
Interventions
DEVICENeurolens
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.
DEVICEPlacebo spectacle lens
Plano (no power) spectacle lenses will be assigned to the placebo group
Sponsors
Neurolens Inc.
Southern California College of Optometry at Marshall B. Ketchum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Contact Lens Discomfort | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Convergence Insufficiency Symptoms | Baseline and 30-35 days | Change in convergence insufficiency symptoms measured by the Convergence Insufficiency Symptom Survey (CISS), Score range 0 - 60 points, Higher scores indicate worse symptoms |
| Change in Headache Symptoms | Baseline and 30-35 days | Change in headache symptoms measured by the Headache Impact Test (HIT-6), Score range: 36 - 78 points, Higher scores indicate worse symptoms |
| Change in Dry Eye Symptoms | Baseline and 30-35 days | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neurolens Treatment Participants will receive Neurolens lenses (measured with the Neurolens device while wearing their habitual contact lenses) in their study spectacles
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. | 14 |
| Placebo Lens Participants will receive plano (no power) lenses in their study spectacles
Placebo spectacle lens: Plano (no power) spectacle lenses will be assigned to the placebo group | 15 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Neurolens Treatment | Placebo Lens | Total |
|---|---|---|---|
| Age, Continuous | 24.57 years STANDARD_DEVIATION 2.14 | 26.20 years STANDARD_DEVIATION 3.26 | 25.41 years STANDARD_DEVIATION 2.85 |
| Mean Contact Lens Wear Time (days/week) | 5.79 days/week STANDARD_DEVIATION 1.25 | 5.53 days/week STANDARD_DEVIATION 1.46 | 5.66 days/week STANDARD_DEVIATION 1.32 |
| Mean Contact Lens Wear Time (hours/day) | 10.79 hours/day STANDARD_DEVIATION 3.58 | 10.80 hours/day STANDARD_DEVIATION 3.63 | 10.79 hours/day STANDARD_DEVIATION 3.48 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 14 participants | 15 participants | 29 participants |
| Sex/Gender, Customized Gender Chose not to declare | 2 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Gender Female | 2 Participants | 2 Participants | 4 Participants |
| Sex/Gender, Customized Gender Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurolens Treatment | Change in Contact Lens Discomfort | -4.94 Scores on a scale | Standard Deviation 3.84 |
| Placebo Lens | Change in Contact Lens Discomfort | -8.67 Scores on a scale | Standard Deviation 5.03 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurolens Treatment | Change in Convergence Insufficiency Symptoms | -8.86 Scores on a scale | Standard Deviation 7.63 |
| Placebo Lens | Change in Convergence Insufficiency Symptoms | -8.93 Scores on a scale | Standard Deviation 9.58 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurolens Treatment | Change in Dry Eye Symptoms | -4.29 Scores on a scale | Standard Deviation 4.3 |
| Placebo Lens | Change in Dry Eye Symptoms | -6.67 Scores on a scale | Standard Deviation 4.47 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurolens Treatment | Change in Headache Symptoms | -3.14 Scores on a scale | Standard Deviation 9.69 |
| Placebo Lens | Change in Headache Symptoms | -9.73 Scores on a scale | Standard Deviation 9.63 |