Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
NCT06967051

The Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults

Led by Sobereye Inc. · Updated on 2025-07-17

20

Participants Needed

1

Research Sites

10 weeks

Total Duration

On this page

Sponsors

S

Sobereye Inc.

Lead Sponsor

K

KGK Science Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this open label study is to evaluate the efficacy of smart phone-based test (SOBEREYE OPTOVERA) on measuring pupillary light reflex (PLR) alterations following cannabis use healthy in adults. The main question it aims to answer is: Can SOBEREYE OPTOVERA detect PLR alterations following cannabis consumption in healthy adults, in comparison to a pupillometer? Participants will be given two 5 mg capsules to be ingested for the 10 mg THC dose or five 5 mg capsules to be ingested for the 25 mg THC. Participants will be asked to complete PLR tests throughout the study day.

CONDITIONS

Official Title

The Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females 21 years of age or older
  • Females not of child-bearing potential (sterilized or post-menopausal for at least 1 year) or, if of child-bearing potential, must have a negative pregnancy test and agree to use approved birth control during the study
  • Self-reported cannabis users familiar with THC effects without severe adverse reactions
  • Cannabis use at least 3 times per month but no more than 3 times per week
  • Agree to abstain from cannabis for 3 days before the study visit
  • Willing to complete all study assessments and arrange safe transportation home
  • Provided voluntary, written informed consent to participate
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Allergy, sensitivity, intolerance, or dietary restrictions preventing consumption of study products
  • Current or ongoing neurological or eye issues affecting the retina or pupil (including blindness, glaucoma, dry eyes, retinal diseases, pupil abnormalities, cataracts, light sensitivity)
  • History of eye or retina surgery except laser corneal surgery
  • Current or past psychological disorders such as schizophrenia or psychosis
  • Significant gastrointestinal diseases
  • Type I or II diabetes with diabetic retinopathy
  • Unstable metabolic or chronic diseases
  • Unstable hypertension unless on stable medication for at least 3 months
  • Significant cardiovascular event in past 6 months unless stable on medication
  • Kidney or liver diseases except resolved kidney stones
  • Confirmed thyroid condition unless stable on medication for at least 3 months
  • Major surgery in past 3 months or planned during study
  • Cancer except fully excised basal cell carcinoma or remission over 5 years
  • Unstable autoimmune disease
  • HIV, Hepatitis B or C infection
  • Alcohol or drug abuse in last 12 months
  • Impairment from drugs or alcohol during study visit
  • Alcohol intake averaging more than 2 standard drinks per day
  • Use of medications, supplements, or foods affecting study product safety or efficacy
  • Participation in other research within 30 days prior to baseline
  • Cognitive impairment or inability to give informed consent
  • Any condition or lifestyle factor posing risk or affecting study completion as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

KGK Science Inc.

London, Ontario, Canada

Actively Recruiting

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Research Team

E

Erin Lewis, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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