Trial Outcomes & Findings for Neurolens and Contact Lens Discomfort (NCT NCT05801991)
NCT ID: NCT05801991
Last Updated: 2025-04-22
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline and 30-35 days
Results posted on
2025-04-22
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Neurolens Treatment
n=14 Participants
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.
|
Placebo Lens
n=15 Participants
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
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.57 years
STANDARD_DEVIATION 2.14 • n=14 Participants
|
26.20 years
STANDARD_DEVIATION 3.26 • n=15 Participants
|
25.41 years
STANDARD_DEVIATION 2.85 • n=29 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
10 Participants
n=14 Participants
|
13 Participants
n=15 Participants
|
23 Participants
n=29 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
2 Participants
n=14 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=29 Participants
|
|
Sex/Gender, Customized
Gender · Chose not to declare
|
2 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
15 participants
n=15 Participants
|
29 participants
n=29 Participants
|
|
Mean Contact Lens Wear Time (hours/day)
|
10.79 hours/day
STANDARD_DEVIATION 3.58 • n=14 Participants
|
10.80 hours/day
STANDARD_DEVIATION 3.63 • n=15 Participants
|
10.79 hours/day
STANDARD_DEVIATION 3.48 • n=29 Participants
|
|
Mean Contact Lens Wear Time (days/week)
|
5.79 days/week
STANDARD_DEVIATION 1.25 • n=14 Participants
|
5.53 days/week
STANDARD_DEVIATION 1.46 • n=15 Participants
|
5.66 days/week
STANDARD_DEVIATION 1.32 • n=29 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30-35 daysChange 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
Outcome measures
| Measure |
Neurolens Treatment
n=14 Participants
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.
|
Placebo Lens
n=15 Participants
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
|
|---|---|---|
|
Change in Contact Lens Discomfort
|
-4.94 Scores on a scale
Standard Deviation 3.84
|
-8.67 Scores on a scale
Standard Deviation 5.03
|
SECONDARY outcome
Timeframe: Baseline and 30-35 daysChange in convergence insufficiency symptoms measured by the Convergence Insufficiency Symptom Survey (CISS), Score range 0 - 60 points, Higher scores indicate worse symptoms
Outcome measures
| Measure |
Neurolens Treatment
n=14 Participants
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.
|
Placebo Lens
n=15 Participants
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
|
|---|---|---|
|
Change in Convergence Insufficiency Symptoms
|
-8.86 Scores on a scale
Standard Deviation 7.63
|
-8.93 Scores on a scale
Standard Deviation 9.58
|
SECONDARY outcome
Timeframe: Baseline and 30-35 daysChange in headache symptoms measured by the Headache Impact Test (HIT-6), Score range: 36 - 78 points, Higher scores indicate worse symptoms
Outcome measures
| Measure |
Neurolens Treatment
n=14 Participants
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.
|
Placebo Lens
n=15 Participants
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
|
|---|---|---|
|
Change in Headache Symptoms
|
-3.14 Scores on a scale
Standard Deviation 9.69
|
-9.73 Scores on a scale
Standard Deviation 9.63
|
SECONDARY outcome
Timeframe: Baseline and 30-35 daysChange 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
Outcome measures
| Measure |
Neurolens Treatment
n=14 Participants
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.
|
Placebo Lens
n=15 Participants
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
|
|---|---|---|
|
Change in Dry Eye Symptoms
|
-4.29 Scores on a scale
Standard Deviation 4.30
|
-6.67 Scores on a scale
Standard Deviation 4.47
|
Adverse Events
Neurolens Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Erin Rueff, OD, PhD (Principal Investigator)
Southern California College of Optometry
Phone: 714-463-7586
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place