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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
Scientific title
A Phase 1 Randomized, Prospective, Double-Masked, Vehicle-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Clinical Effect of Nexagon™ in Subjects Following Bilateral Photorefractive Keratectomy (PRK) for the Correction of Mild to Moderate Myopia.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Corneal re-Epithelialization 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Nexagon™ or Nexagon™ vehicle

Experimental: 1 -

Treatment: Drugs: Nexagon™ or Nexagon™ vehicle
Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
30 days post-application
Secondary outcome [1] 0 0
To evaluate the clinical effect of Nexagon™
Timepoint [1] 0 0
30 days post-application

Key inclusion criteria
- Male or female pre-presbyopic myopes.

- Aged between 20 and 50 years inclusive.

- Females are eligible to participate only if they are currently non-pregnant and
non-lactating. Females of child-bearing potential must commit to consistent and
correct use of an acceptable method of birth control.

- Subjects willing and able to undergo bilateral PRK for the correction of their myopia.

- Subjects with MRSE <6.0 D, with less than 2.0 D of astigmatism.

- No more than 1.0 D of refractive difference between eyes.

- Stable prescription in both eyes as defined by <0.25 D change over the preceding 2

- Subjects who are able to comply with all study procedures, including wearing a soft
bandage contact lens in the immediate postoperative period.

- Subjects who are willing and able to give written informed consent to take part in the
Minimum age
20 Years
Maximum age
50 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Subjects who have a past or present disease, which as judged by the investigator may
affect the safety of the subject or the outcome of the study.

- Subjects who have previously had corneal surgery.

- Subjects who require Mitomycin C following their PRK.

- Subjects with any ocular disease or corneal abnormality, including but not limited to:

- Decreased corneal sensation / neurotrophic cornea;

- Corneal vascularization;

- Keratoconus;

- Keratoconjunctivitis sicca requiring chronic treatment;

- Lagophthalmos;

- Blepharitis;

- History of infectious keratitis;

- History of glaucoma or intraocular pressure of >21 mmHg or use of glaucoma

- Significant dry eye disease that requires regular topical treatment;

- Corneal thickness <480 µm at the thinnest point, and

- Posterior elevation >40 mmHg.

- Subjects with corneal haze >+1 as assessed using the grading scale in the protocol.

- Subjects who require any topical ophthalmic medication other than the pre- and
postoperative regimen defined in the study protocol.

- Subjects with:

- Diabetes;

- Collagen disorders associated with autoimmune diseases, e.g., lupus, rheumatoid

- Severe atopic disease;

- Any systemic disease or condition where the subject is immunocompromized.

- Subjects who require any systemic medication that affects healing, e.g., steroids,
hormone replacement therapy.

- Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine,
scopolamine, or medications or agents that can cause dry eye.

- Subjects who have participated in a clinical trial within the 30 days prior to the
date on which PRK is scheduled.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
OcuNexus Therapeutics, Inc.

Ethics approval
Ethics application status

Brief summary
Phase 1 randomized, prospective, double-masked, vehicle-controlled, dose-escalation study to
evaluate the safety, tolerability and clinical effect of Nexagon™ in subjects following
bilateral PRK for the correction of mild to moderate myopia.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Sue Ormonde, MD, FRC Ophth, FRANZCO
Address 0 0
Auckland Eye
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications