A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication

This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.

Inclusion Criteria:Male or female healthy volunteersAge 18 to 65 yearsBMI between 18.5-30 kg/m2Weight between 50-100 kgHealthy as determined by the investigator or designee based on pre-study medical and surgical history and a health examination at enrollmentWomen of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and at visit 2 and must agree to use a medically acceptable contraception from enrollment until study completionNo current drug usage defined as a negative urine drug test at enrollment and at visit 2Able to use Previct Drugs after initial training (defined as successfully performing a test after trying maximum three times per measurement)Been informed of the nature, the scope, and the relevance of the clinical investigationVoluntarily agreed on participation and has duly singed the Informed Consent FormExclusion Criteria:Participating in another clinical investigation which may affect the study outcome according to clinical judgementPregnancy or LactatingBlindDeafAbnormal ECG (QTc time >450 ms) at enrollmentCurrent or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuseCurrent or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical judgementAny disease or condition that may influence pupillary reflexes based on clinical judgementUndergone eye surgery that may influence pupillary reflexes based on clinical judgementOngoing treatment with medications which may interfere with eye measurements based on clinical judgementOngoing treatment with medications which may interfere with any of the medicinal products to be usedHistory or presence of allergy or serious reaction to the medicinal products to be usedHistory or presence of cardiovascular disease, e.g., arteriosclerosis, hypertension, or cor pulmonaleHistory or presence of sleep-related breath disorderHistory or presence of gastrointestinal disease, e.g., paralytic ileus, acute abdomen, delayed gastric emptying, or chronic constipationHistory or presence of pulmonary disease, e.g., acute pulmonary insufficiency, severe respiratory depression with hypoxia, chronic obstructive lung disease, or bronchial asthmaHistory or presence of autoimmune neuromuscular disease, e.g., myasthenia gravisNot able to read or understand the local languageAny other condition that as judged by the investigator may make the follow-up or investigation inappropriateThat according to the Declaration of Helsinki is deemed unsuitable for study enrollment