None listed
Conditions
Brief summary
The study will be a multi-center, open-label, single-dose, parallel-arm evaluation of the ocular effect and safety of NVK031 in healthy volunteers with brown eyes and non-brown eyes. In this study, four test products of NVK031 will be evaluated. Approximately 44 eligible subjects will be healthy volunteers who are 18 to 55 years old and free of clinically significant ocular pathology. The primary objectives are to identify a MED and to assess the overall effect of NVK031 on the change from baseline (pre-dose at Visit 2) in mesopic pupil diameter for subjects receiving the MED.
Interventions
NVK031 is an investigational sterile ophthalmic solution for topical administration to the eye.
Mode of Administration: NVK031 (test products A, B, C or D) will be dosed by topical ocular administration.
Dose is only single administration- single drop in each eye.
Observation period is 6hr post-dose.
Study is open-label. Each cohort is assigned a specific concentration of NVK031.
method of allocation used in this form: Cohort dosing with one cohort open at a time and balanced for eye colour (b
NVK031 is an investigational sterile ophthalmic solution for topical administration to the eye. Mode of Administration: NVK031 (test products A, B, C or D) will be dosed by topical ocular administration. Dose is only single administration- single drop in each eye. Observation period is 6hr post-dose. Study is open-label. Each cohort is assigned a specific concentration of NVK031. method of allocation used in this form: Cohort dosing with one cohort open at a time and balanced for eye colour (brown vs non-brown). The four concentrations of NVK031 are (0.75%, 0.5%, 0.29%, and 0.08%). Strategy used to monitor adherence to the intervention: Not applicable – single dose is administered by site staff at clinic visit.
Sponsors
Nevakar, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age greater than or equal to 18 to less than or equal to 55 years 2. Subjects must be in good general health, with no significant medical problems that, in the opinion of the investigator, would preclude participation in the trial, at Screening and/or before administration of NVK031 3. Photopic high-contrast CCVA better than or equal to 20/25 in both eyes at Screening 4. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Screening 5. Nature of the study has been explained and prior to the commencement of any study procedures
Exclusion criteria
1. History of any corneal abnormality (e.g., keratoconus, pellucid marginal degeneration, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that is likely to interfere with visual acuity 2. Serious systemic illness that, in the opinion of the Investigator’s, would render the subject ineligible 3. Pre-planned hospitalization or ocular or systemic surgery during the study period 4. Present history of any substance abuse (alcohol and/or illegal drugs) 5. Participation in any other study of investigational therapy during the study period or within the last 30 days or 5 half-lives, whichever is longer 6. Unwilling or unable to complete study procedures or to be followed up for the duration of the study
Outcome results
None listed