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

NCT06967051 | Recruiting

• 1 other identifier: 24SICFP01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cannabis Intoxication; Drug Effects

Keywords

Pupillometer; Cannabis Use; Drug Effects; SOBEREYE; OPTOVERA; Pupillary Light Reflex

Outcome Measures

Primary Outcomes (28)

• The difference in change in Pupillary Light Reflex (PLR) measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.

  T=0 to T=5 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=30 min.

  T=0 to T=30 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=60 min.

  T=0 to T=60 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=120 min.

  T=0 to T=120 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=180 min.

  T=0 to T=180 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=240 min.

  T=0 to T=240 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=300 min.

  T=0 to T=300 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=360 min.

  T=0 to T=360 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=420 min.

  T=0 to T=420 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=480 min.

  T=0 to T=480 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.

  T=0 to T=5 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=30 min.

  T=0 to T=30 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=60 min.

  T=0 to T=60 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=120 min.

  T=0 to T=120 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=180 min.

  T=0 to T=180 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=240 min.

  T=0 to T=240 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=300 min.

  T=0 to T=300 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=360 min.

  T=0 to T=360 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil reflexes (absolute contraction and latency) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=480 min.

  T=0 to T=480 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer in pupil size from time (T)=0 minutes (min) at T=5 min.

  T=0 to T=5 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=30 min.

  T=0 to T=30 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=60 min.

  T=0 to T=60 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=120 min.

  T=0 to T=120 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=180 min.

  T=0 to T=180 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=240 min.

  T=0 to T=240 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=300 min.

  T=0 to T=300 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=360 min.

  T=0 to T=360 minutes

• The difference in change in PLR measures between a smart phone-based test and NeuroLight pupillometer

  The difference in change in pupil activity as measured by pupillary unrest in ambient light (hippus) between a smart phone-based test and NeuroLight pupillometer from time (T)=0 minutes (min) at T=480 min.

  T=0 to T=480 minutes

Secondary Outcomes (18)

• The difference in change in reaction time

  T= 0 at T=60 minutes

• The difference in change in reaction time

  T= 0 at T=120 minutes

• The difference in change in reaction time

  T= 0 at T=180 minutes

• The difference in change in reaction time

  T= 0 at T=240 minutes

• The difference in change in reaction time

  T= 0 at T=300 minutes

Other Outcomes (1)

• Clinically relevant post-emergent adverse events

  T=0 to T=480 minutes

Study Arms (2)

Tetrahydrocannabinol (10 mg)

EXPERIMENTAL

10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule.

Drug: Tetrahydrocannabinol (10 mg); Diagnostic Test: Pupillary Light Reflex (PLR) Test; Diagnostic Test: Pupillometer

Tetrahydrocannabinol (25 mg)

EXPERIMENTAL

25 mg of THC provided as a softgel capsule.

Drug: Tetrahydrocannabinol (25 mg); Diagnostic Test: Pupillary Light Reflex (PLR) Test; Diagnostic Test: Pupillometer

Interventions

Tetrahydrocannabinol (10 mg) DRUG

10 mg of Tetrahydrocannabinol (THC) provided as a softgel capsule

Tetrahydrocannabinol (10 mg)

Tetrahydrocannabinol (25 mg) DRUG

25 mg of THC provided as a softgel capsule.

Tetrahydrocannabinol (25 mg)

Pupillary Light Reflex (PLR) Test DIAGNOSTIC_TEST

SOBEREYE OPTOVERA is a portable, non-invasive test that measures the Pupillary Light Reflex (PLR)

Tetrahydrocannabinol (10 mg); Tetrahydrocannabinol (25 mg)

Pupillometer DIAGNOSTIC_TEST

NeuroLight is an automated pupillometer that generates a flash of light and measures the photomotor reflex very accurately.

Tetrahydrocannabinol (10 mg); Tetrahydrocannabinol (25 mg)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 21 years of age or older
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if planning on becoming sexually active during the study
• Self-reported cannabis users based on the Cannabis Use Questionnaire who are familiar and experienced with THC's acute psychoactive effects from the doses and route of administration to be used in this study without previous severe adverse reactions after cannabis ingestion
• Self-reported cannabis use at least 3x per month but no more than 3x per week
• Agrees to abstain from cannabis use for 3 days prior to study visit
• Willingness to complete all assessments associated with the study and agrees to safe transportation home
• Provided voluntary, written, informed consent to participate in the study

You may not qualify if:

• Individuals who are pregnant, breast feeding or planning to become pregnant during the study
• Allergy, sensitivity, intolerance, or dietary restriction preventing consumption study products
• Current and ongoing neurological or ophthalmological issue that could affect the retina (blindness, glaucoma, dry eyes, retinal diseases, pupil abnormalities, cataracts, sensitivity to bright lights)
• History of surgery on eyes or retinas except for laser corneal surgery
• Current or history of psychological disorders (e.g., schizophrenia and psychosis)
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Type I or Type II diabetes with diabetic retinopathy
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (see below)
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an unstable autoimmune disease

Sponsors & Collaborators

• Sobereye Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, Canada

RECRUITING

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lewis, PhD

CONTACT

1-226-242-4551; elewis@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label pilot study

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 13, 2025
• Study Start: May 22, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)