Neurolens Headache Study

Sponsor

Neurolens Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05070767

Collaborator

(none)

250

Enrollment

Locations

Arms

6.4

Anticipated Duration (Months)

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To understand the benefits of the neurolens Measurement Device and neurolens treatment as it pertains to treating symptoms related to Chronic Headaches. It is a Prospective randomized double masked two arm performed on a minimum of 200 to a maximum of 300 subjects identified as symptomatic (HIT-6 questionnaire score equal to or greater than 56) done across 3-15 clinical sites. There are two subgroups: a minimum of 100 in each subgroup (subgroup 1: pre-presbyopic (18-40 years); subgroup 2: presbyopic subjects (41-60 years).

Condition or Disease	Intervention/Treatment	Phase
Binocular Vision Disorder Convergence Insufficiency Headache Computer Vision Syndrome	Device: Neurolens spectacle lens Device: Placebo spectacle lens	N/A

Detailed Description

This study is a two-arm crossover study with two subgroups. Subjects will initially be assessed for their headache symptoms (Headache Impact Test (HIT-6) questionnaire) and then are provided an updated refractive prescription and will wear them for 35 ± 5 days. Symptoms will be reassessed after the 35-day control break in. If the subject's symptoms have subsided, they will be exited from the study and will keep their lenses. Provided the subject has symptoms (HIT questionnaire score ≥ 56) after their 35-day use of their updated prescription and they continue to meet the inclusion/exclusion criteria they will proceed to the evaluation portion of the protocol. The first arm receiving neurolens first and the second arm receiving the control first. The control is a single vision or PAL lens which yields the BCDVA and BCNVA of a test subject with no prismatic correction. The neurolens prescribed prism will be based on the practitioner's Rx using the subject's best response to a prism trial lens and must be within a half prism diopter of the neurolens value output of the neurolens Measurement Device and providing the subject's BCDVA and BCNVA. Participants will come back after 35 day wear of their first test lens and the symptom questionnaire is reassessed. They will be now be crossed over to the second pair of study lenses (i.e. subjects in the first arm will not receive control lens and the ones in the second arm will not receive neurolens). Participants will come back after 35 day wear of their second test lens and the symptom questionnaire is reassessed for the final time.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Prospective randomized double masked two armProspective randomized double masked two arm

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Prospective randomized double masked two arm

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Double Masked Two Arm Cross-over Study of Neurolenses in Subjects With Headaches

Actual Study Start Date :

Oct 18, 2021

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurolens Our proprietary contoured prism lens design, commercially known as neurolens.	Device: Neurolens spectacle lens spectacle lens
Placebo Comparator: Control lens A simple refractive error correction lens	Device: Placebo spectacle lens spectacle lens for refractive error correction

Arm

Intervention/Treatment

Experimental: Neurolens

Our proprietary contoured prism lens design, commercially known as neurolens.

Device: Neurolens spectacle lens

spectacle lens

Placebo Comparator: Control lens

A simple refractive error correction lens

Device: Placebo spectacle lens

spectacle lens for refractive error correction

Outcome Measures

Primary Outcome Measures

Headache Impact Test (HIT-6) questionnaire [30-40 days]
Change in headache impact test (HIT-6) with the use of neurolenses compared to control lenses. The minimum response score for each question is 6 and the maximum is 13. Larger scores would indicate a more symptomatic patient. Larger difference in the cumulative response score between treatment visit and the baseline visit would indicate a greater impact of the treatment.

Secondary Outcome Measures

Patients with reduced near point of convergence (NPC) [30-40 days]
Change in the headache impact test (HIT-6) score with the use of neurolens compared to control lenses in subjects with reduced Near point of convergence (NPC). The minimum response score for each question is 6 and the maximum is 13. Larger scores would indicate a more symptomatic patient. Larger difference in the cumulative response score between treatment visit and the baseline visit would indicate a greater impact of the treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female, and between 18-60 years of age at the time of signing the informed consent.
Best Corrected distance and near acuity are equal to or better than 20/25 Snellen Equivalent in each eye.
Best Corrected distance and near binocular acuity are equal to or better than 20/25 Snellen Equivalent.
Symptomatic as indicated by the HIT-6 questionnaire (Score equal to or greater than

Updated distance spectacle prescription must match the following

Spherical power inclusive between +4.00D to -8.00D b. Cylinder power no more than -4.00Dcyl c. ADD power i. Subgroup 1: No ADD ii. Subgroup 2: minimum +1.00D ADD

Subjects' eye alignment tests must match the following:

Successful measurement on the neurolens Measurement Device (Acceptable MQI and a numerical neurolens Value, no Low MQI or Convergence Excess)

Minimum stereo vision of 50 seconds of arc at 16 inches
Capable of committing to the duration of the study.
Willing to comply with study procedures

Exclusion Criteria:

Subjects who need a vertical prism.
Previously has worn neurolenses.
Subjects who need a near add less than 1.00D
Use of contact lenses during the study
Lack of binocular vision, including strabismus, amblyopia, or suppression.
Greater than 20 prism diopter of eye misalignment.
Aniseikonia greater than 3.00D spherical equivalent difference between eyes
Prior ocular surgery that in the estimation of the practitioner induces corneal scarring (RK, Corneal Transplant, etc.) or prior surgery involving the extraocular muscles (strabismus surgery). Surgeries that do not affect these parameters such as LASIK, PRK, or pterygium surgery are allowed.
Anterior segment conditions that could obfuscate or obscure reflections from the cornea, or reduce visual acuity, including but not limited to corneal scarring, large pinguecula, pterygium, keratoconus, dermatochalasis, ptosis, exophthalmos or cataract.
Clinical dry eye (defined as tear break-up time of less than 5 seconds)
Intraocular pressures greater than 25 mmHg in either eye or uncontrolled glaucoma
Macular disease, or any posterior segment finding which in the opinion of the investigator is visually and/or clinically significant
Change in acute or prophylactic migraine treatment medication or dosage within the previous two months.
Diabetes with ocular manifestation
Previous head or neck trauma (for instance, car accident, etc.) requiring medical intervention.
Open lesions or sores around the chin or eyes that will make contact with the device and may be subject to contraction or spread of infection.
Physical tremors or muscle spasms that prevent a subject from sitting still.
A history of seizures or seizure disorder.
Women who are pregnant or lactating at the time of the study entry
Mental incapacity that prevents a subject from being able to follow simple instructions such as "look at the target."

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Vision and Achievement Center	Phoenix	Arizona	United States	85051
2	The Eye Center	Conyers	Georgia	United States	30012
3	Advanced Eyecare Center	Perry	Georgia	United States	31069
4	Eyecare of Rigby	Rigby	Idaho	United States	83442
5	Signature Eye Care	Lincoln	Nebraska	United States	68516
6	Buckeye Family Eye Clinic	Hillsboro	Ohio	United States	45133
7	Preferred Eye Care Center	Mount Pleasant	South Carolina	United States	29466
8	Kapperman White and McGarvey	Chattanooga	Tennessee	United States	37421
9	Springhill Eye Care	Spring Hill	Tennessee	United States	37174
10	Eyes for Life	Spokane	Washington	United States	99203