The Efficacy of a Smart Phone-based Test on Measuring Pupillary Light Reflex Alterations Following Cannabis Use Healthy in Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorSobereye Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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,
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tetrahydrocannabinol (10 mg)
- Tetrahydrocannabinol (25 mg)
- Pupillary Light Reflex (PLR) Test
- Pupillometer
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sobereye Inc.
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov