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CompletedNCT06967051Updated Oct 6, 2026

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

An interventional study of Tetrahydrocannabinol (10 mg) and Tetrahydrocannabinol (25 mg) in Cannabis Intoxication and Drug Effects, sponsored by Sobereye Inc.. Completed at 1 site in Canada. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Sobereye Inc. · Not applicable, Interventional, and Diagnostic

Updated Oct 6, 2026Now CompletedStart date moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cannabis Intoxication
  • Drug Effects

Keywords

  • Pupillometer
  • Cannabis Use
  • Drug Effects
  • SOBEREYE
  • OPTOVERA
  • Pupillary Light Reflex
03

In context

Lead sponsor

This is the only study on the registry with Sobereye Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males and females 21 years of age or older

  2. 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:

    1. 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)
    2. Double-barrier method
    3. Intrauterine devices
    4. Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
    5. Vasectomy of partner at least 6 months prior to screening
    6. Abstinence and agrees to use contraception if planning on becoming sexually active during the study
  3. 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
  4. Self-reported cannabis use at least 3x per month but no more than 3x per week
  5. Agrees to abstain from cannabis use for 3 days prior to study visit
  6. Willingness to complete all assessments associated with the study and agrees to safe transportation home
  7. Provided voluntary, written, informed consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Individuals who are pregnant, breast feeding or planning to become pregnant during the study
  2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption study products
  3. 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)
  4. History of surgery on eyes or retinas except for laser corneal surgery
  5. Current or history of psychological disorders (e.g., schizophrenia and psychosis)
  6. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
  7. Type I or Type II diabetes with diabetic retinopathy
  8. Unstable metabolic disease or chronic diseases as assessed by the QI
  9. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (see below)
  10. 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
  11. 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
  12. 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
  13. 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
  14. 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
  15. Individuals with an unstable autoimmune disease
  16. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  17. Alcohol or drug abuse within the last 12 months
  18. Impairment from illicit drugs or alcohol during their study visit, as assessed by the QI or Sub-Investigator
  19. Alcohol intake average of >2 standard drinks per day as assessed by the QI
  20. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (see below)
  21. Participation in other research studies 30 days prior to baseline, as assessed by the QI
  22. Individuals who are cognitively impaired and/or who are unable to give informed consent
  23. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Tetrahydrocannabinol (10 mg)

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

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

  • Experimental
    Tetrahydrocannabinol (25 mg)

    25 mg of THC provided as a softgel capsule.

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

Interventions

  • DrugTetrahydrocannabinol (10 mg)

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

  • DrugTetrahydrocannabinol (25 mg)

    25 mg of THC provided as a softgel capsule.

  • Diagnostic testPupillary Light Reflex (PLR) Test

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

  • Diagnostic testPupillometer

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: T=0 to T=5 minutes

  2. 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.

    Time frame: T=0 to T=30 minutes

  3. 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.

    Time frame: T=0 to T=60 minutes

  4. 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.

    Time frame: T=0 to T=120 minutes

  5. 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.

    Time frame: T=0 to T=180 minutes

  6. 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.

    Time frame: T=0 to T=240 minutes

  7. 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.

    Time frame: T=0 to T=300 minutes

  8. 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.

    Time frame: T=0 to T=360 minutes

  9. 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.

    Time frame: T=0 to T=420 minutes

  10. 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.

    Time frame: T=0 to T=480 minutes

  11. 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.

    Time frame: T=0 to T=5 minutes

  12. 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.

    Time frame: T=0 to T=30 minutes

  13. 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.

    Time frame: T=0 to T=60 minutes

  14. 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.

    Time frame: T=0 to T=120 minutes

  15. 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.

    Time frame: T=0 to T=180 minutes

  16. 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.

    Time frame: T=0 to T=240 minutes

  17. 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.

    Time frame: T=0 to T=300 minutes

  18. 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.

    Time frame: T=0 to T=360 minutes

  19. 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.

    Time frame: T=0 to T=480 minutes

  20. 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.

    Time frame: T=0 to T=5 minutes

  21. 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.

    Time frame: T=0 to T=30 minutes

  22. 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.

    Time frame: T=0 to T=60 minutes

  23. 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.

    Time frame: T=0 to T=120 minutes

  24. 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.

    Time frame: T=0 to T=180 minutes

  25. 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.

    Time frame: T=0 to T=240 minutes

  26. 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.

    Time frame: T=0 to T=300 minutes

  27. 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.

    Time frame: T=0 to T=360 minutes

  28. 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.

    Time frame: T=0 to T=480 minutes

Secondary outcomes

  1. The difference in change in reaction time

    The difference in change in reaction time as assessed by Dynavision from T= 0 at T=60 minutes

    Time frame: T= 0 at T=60 minutes

  2. The difference in change in reaction time

    The difference in change in reaction time as assessed by Dynavision from T= 0 at T=120 min

    Time frame: T= 0 at T=120 minutes

  3. The difference in change in reaction time

    The difference in change in reaction time as assessed by Dynavision from T= 0 at T=180 minutes

    Time frame: T= 0 at T=180 minutes

  4. The difference in change in reaction time

    The difference in change in reaction time as assessed by Dynavision from T= 0 at T=240 minutes

    Time frame: T= 0 at T=240 minutes

  5. The difference in change in reaction time

    The difference in change in reaction time as assessed by Dynavision from T= 0 at T=300 minutes

    Time frame: T= 0 at T=300 minutes

  6. The difference in change in reaction time

    The difference in change in reaction time as assessed by Dynavision from T= 0 at T=360 min

    Time frame: T= 0 at T=360 minutes

  7. The difference in change in reaction time

    The difference in change in reaction time as assessed by Dynavision from T= 0 at T=420 min

    Time frame: T= 0 at T=420 minutes

  8. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T= 5 min, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T= 5 minutes

  9. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=30 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=30 minutes

  10. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=60 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=60 minutes

  11. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=90 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=90 minutes

  12. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=120 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=120 minutes

  13. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=180 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=180 minutes

  14. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=240 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=240 minutes

  15. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=300 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=300 minutes

  16. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=360 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=360 minutes

  17. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=420 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=420 minutes

  18. The difference in change in subjective drug effects

    The difference in change in subjective drug effects as assessed by the modified Drug Effects Questionnaire (DEQ) from T=0 at T=480 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 at T=480 minutes

Other outcomes

  1. Clinically relevant post-emergent adverse events

    Clinically relevant post-emergent adverse events at T=0 to T=480 minutes. Including via the modified Drug Effects Questionnaire (DEQ) from T=0 at T=480 minutes, on a scale of 1 to 10. Higher score indicates higher subjective drug effect.

    Time frame: T=0 to T=480 minutes

07

Study locations

1 site
  • KGK Science Inc.
    London, Ontario, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 6, 2026
Start date
May 22, 2025→May 27, 2025
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Completed
    Start date May 22, 2025→May 27, 2025
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06967051
Lead sponsor
Sobereye Inc.
Collaborators
KGK Science Inc.
Responsible party
Sponsor
First posted
May 13, 2025
Start date
May 27, 2025
Primary completion
Aug 19, 2025
Completion
Aug 19, 2025
Last update
Oct 6, 2026

Study contacts

David Crowley, MD
principal investigator · KGK Science Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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