Study to Assess the Minimum Effective Concentration of NVK031 on Pupillary Constriction andDistance Vision in Healthy Volunteers
- Conditions
- ormal eye functionNormal eye functionEye - Normal eye development and function
- Registration Number
- ACTRN12621000351819
- Lead Sponsor
- evakar, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of eyes that demonstrate pupil constriction in each dose group.<br>Outcome is measured by a digital pupilometer. [Measured on Day 1(Dosing day) post-dose(1, 2, 3, 4, 6-hour time points).]
- Secondary Outcome Measures
Name Time Method Incidence and percentage of ocular and non-ocular adverse events. <br>It is a composite outcome. Outcomes is assessed via Medical Dictionary for Regulatory Activities (MedDRA).[Measured from baseline till the end of the study (Day 8 post-dose)]