Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00654550




Registration number
NCT00654550
Ethics application status
Date submitted
3/04/2008
Date registered
8/04/2008
Date last updated
8/01/2009

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
NEX-OCU-001
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
years.

- 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
study.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
medications;

- 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
arthritis;

- 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
Treatment
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00654550
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00654550