Corneal re-EpithelializationPhase 1NCT00654550
A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
A Phase 1 study of Corneal re-Epithelialization, run by OcuNexus Therapeutics, Inc. at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Corneal re-Epithelialization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNew Zealand
- Study dates
- Apr 2008to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
- Conditions
- Corneal re-Epithelialization
- Being tested
- Nexagon™ or Nexagon™ vehicle
- Keywords
- Photorefractive keratectomy, Re-epithelialization, Nexagon, PRK, Coda
- Medical subject headings
- Cavitary Optic Disc Anomalies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexagon™ or Nexagon™ vehicleDrug
Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Nexagon™ or Nexagon™ vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 30 days post-application
Secondary outcomes (1)
To evaluate the clinical effect of Nexagon™
Measured: 30 days post-application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal re-EpithelializationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OcuNexus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sue Ormonde, MD, FRC Ophth, FRANZCO, Principal investigator, Auckland Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654550
- Sponsor's protocol ID
- NEX-OCU-001
- Status last verified
- Jan 2009
- First submitted
- 3 Apr 2008
- Last updated
- 8 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00654550
- Acronym / sponsor ID
- NEX-OCU-001
- Conditions
- Corneal re-Epithelialization
- Keywords
- Photorefractive keratectomy, Re-epithelialization, Nexagon, PRK, Coda
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- OcuNexus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nexagon™ or Nexagon™ vehicle |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (25 listed)
- 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:
- Subjects with corneal haze >+1 as assessed using the grading scale in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexagon™ or Nexagon™ vehicleDose-escalation design in which cohorts of 6 subjects will be studied sequentially. | Drug | 1 |
Primary outcome
Incidence of adverse events
Time frame: 30 days post-application
1 secondary outcome
To evaluate the clinical effect of Nexagon™
Time frame: 30 days post-application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2009.
Related trials for Corneal re-Epithelialization
Not yet recruitingPhase 4
Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK
Corneal Epithelial Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Ormonde, MD, FRC Ophth, FRANZCO principal investigator
Auckland Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Corneal re-Epithelialization, run by OcuNexus Therapeutics, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 30 days post-application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2009.