- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05070767
Neurolens Headache Study
Randomized Controlled Double Masked Two Arm Cross-over Study of Neurolenses in Subjects With Headaches
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85051
- Advanced Vision and Achievement Center
-
-
Georgia
-
Conyers, Georgia, United States, 30012
- The Eye Center
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Perry, Georgia, United States, 31069
- Advanced Eyecare Center
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Idaho
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Rigby, Idaho, United States, 83442
- Eyecare of Rigby
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-
Nebraska
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Lincoln, Nebraska, United States, 68516
- Signature Eye Care
-
-
Ohio
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Hillsboro, Ohio, United States, 45133
- Buckeye Family Eye Clinic
-
-
South Carolina
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Mount Pleasant, South Carolina, United States, 29466
- Preferred Eye Care Center
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Tennessee
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Chattanooga, Tennessee, United States, 37421
- Kapperman White and McGarvey
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Spring Hill, Tennessee, United States, 37174
- Springhill Eye Care
-
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Washington
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Spokane, Washington, United States, 99203
- Eyes for Life
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 56)
Updated distance spectacle prescription must match the following
a. 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:
a. 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."
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neurolens
Our proprietary contoured prism lens design, commercially known as neurolens.
|
spectacle lens
|
Placebo Comparator: Control lens
A simple refractive error correction lens
|
spectacle lens for refractive error correction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache Impact Test (HIT-6) questionnaire
Time Frame: 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. |
30-40 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients with reduced near point of convergence (NPC)
Time Frame: 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. |
30-40 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Corina Van De Pol, OD PhD, Neurolens Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NLR - 210720
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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