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Trial registered on ANZCTR


Registration number
ACTRN12621000351819
Ethics application status
Approved
Date submitted
24/11/2020
Date registered
26/03/2021
Date last updated
2/02/2022
Date data sharing statement initially provided
26/03/2021
Date results information initially provided
26/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to Assess the Minimum Effective Concentration of NVK031 on Pupillary Constriction and
Distance Vision in Healthy Volunteers
Scientific title
A Phase 1, Multi-Center, Open-Label, Single-Dose, Parallel-Arm Study to Assess the Minimum Effective Concentration of NVK031 on Pupillary Constriction and Distance Vision in Healthy Volunteers
Secondary ID [1] 302730 0
CP-NVK031-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal eye function 319655 0
Condition category
Condition code
Eye 317587 317587 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319006 0
Treatment: Drugs
Comparator / control treatment
comparator treatment- doses are compared to one another
Control group
Dose comparison

Outcomes
Primary outcome [1] 325629 0
Proportion of eyes that demonstrate pupil constriction in each dose group.
Outcome is measured by a digital pupilometer.
Timepoint [1] 325629 0
Measured on Day 1(Dosing day) post-dose(1, 2, 3, 4, 6-hour time points).
Secondary outcome [1] 388599 0
Incidence and percentage of ocular and non-ocular adverse events.
It is a composite outcome. Outcomes is assessed via Medical Dictionary for Regulatory Activities (MedDRA).
Timepoint [1] 388599 0
Measured from baseline till the end of the study (Day 8 post-dose)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/01/2021
Date of last participant enrolment
Anticipated
Actual
10/02/2021
Date of last data collection
Anticipated
Actual
11/02/2021
Sample size
Target
44
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18076 0
University of Sunshine Coast Health Clinics - Sippy Downs
Recruitment hospital [2] 21625 0
Mark Hinds Optometrists - Teneriffe
Recruitment postcode(s) [1] 32064 0
4556 - Sippy Downs
Recruitment postcode(s) [2] 36553 0
4005 - Teneriffe

Funding & Sponsors
Funding source category [1] 307155 0
Commercial sector/Industry
Name [1] 307155 0
Nevakar, Inc.
Country [1] 307155 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nevakar, Inc.
Address
NJ Center of Excellence, 1019 Route 202/206, Bldg. K Bridgewater, NJ 08807, USA
Country
United States of America
Secondary sponsor category [1] 307743 0
None
Name [1] 307743 0
Address [1] 307743 0
Country [1] 307743 0
Other collaborator category [1] 281527 0
Commercial sector/Industry
Name [1] 281527 0
Novotech (Australia) Pty Ltd
Address [1] 281527 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 281527 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307268 0
Bellberry HREC
Ethics committee address [1] 307268 0
123 Glen Osmond Rd, Eastwood SA 5063, Australia
Ethics committee country [1] 307268 0
Australia
Date submitted for ethics approval [1] 307268 0
28/10/2020
Approval date [1] 307268 0
24/11/2020
Ethics approval number [1] 307268 0
2020-07-694

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106634 0
Dr Susan Thackwray
Address 106634 0
University of the Sunshine Coast – Clinical Trials Centre
Address: 90 Sippy Downs Drive, Sippy Downs QLD 4556
Country 106634 0
Australia
Phone 106634 0
+61 07 54563797
Fax 106634 0
Email 106634 0
[email protected]
Contact person for public queries
Name 106635 0
Ms Rebecca Rosario
Address 106635 0
Nevakar, Inc., NJ Center of Excellence
Address: 1019 Route 202/206, Bldg. K, Bridgewater, NJ 08807, United States of America
Country 106635 0
United States of America
Phone 106635 0
+1 9083677400
Fax 106635 0
Email 106635 0
[email protected]
Contact person for scientific queries
Name 106636 0
Dr Houman Hemmati
Address 106636 0
Nevakar, Inc., NJ Center of Excellence
Address: 1019 Route 202/206, Bldg. K, Bridgewater, NJ 08807, United States of America
Country 106636 0
United States of America
Phone 106636 0
+1 9083677400
Fax 106636 0
Email 106636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
None


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.