Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT00654550
Status:
COMPLETED
Last Update Posted:
2009-01-08
First Post:
2008-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566924', 'term': 'Cavitary Optic Disc Anomalies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-06', 'studyFirstSubmitDate': '2008-04-03', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '30 days post-application'}], 'secondaryOutcomes': [{'measure': 'To evaluate the clinical effect of Nexagon™', 'timeFrame': '30 days post-application'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Photorefractive keratectomy', 'Re-epithelialization', 'Nexagon', 'PRK', 'Coda'], 'conditions': ['Corneal re-Epithelialization']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female pre-presbyopic myopes.\n* Aged between 20 and 50 years inclusive.\n* 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.\n* Subjects willing and able to undergo bilateral PRK for the correction of their myopia.\n* Subjects with MRSE \\<6.0 D, with less than 2.0 D of astigmatism.\n* No more than 1.0 D of refractive difference between eyes.\n* Stable prescription in both eyes as defined by \\<0.25 D change over the preceding 2 years.\n* Subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period.\n* Subjects who are willing and able to give written informed consent to take part in the study.\n\nExclusion Criteria:\n\n* 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.\n* Subjects who have previously had corneal surgery.\n* Subjects who require Mitomycin C following their PRK.\n* Subjects with any ocular disease or corneal abnormality, including but not limited to:\n\n * Decreased corneal sensation / neurotrophic cornea;\n * Corneal vascularization;\n * Keratoconus;\n * Keratoconjunctivitis sicca requiring chronic treatment;\n * Lagophthalmos;\n * Blepharitis;\n * History of infectious keratitis;\n * History of glaucoma or intraocular pressure of \\>21 mmHg or use of glaucoma medications;\n * Significant dry eye disease that requires regular topical treatment;\n * Corneal thickness \\<480 µm at the thinnest point, and\n * Posterior elevation \\>40 mmHg.\n* Subjects with corneal haze \\>+1 as assessed using the grading scale in the protocol.\n* Subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol.\n* Subjects with:\n\n * Diabetes;\n * Collagen disorders associated with autoimmune diseases, e.g., lupus, rheumatoid arthritis;\n * Severe atopic disease;\n * Any systemic disease or condition where the subject is immunocompromized.\n* Subjects who require any systemic medication that affects healing, e.g., steroids, hormone replacement therapy.\n* Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.\n* Subjects who have participated in a clinical trial within the 30 days prior to the date on which PRK is scheduled.'}, 'identificationModule': {'nctId': 'NCT00654550', 'briefTitle': 'A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness', 'organization': {'class': 'INDUSTRY', 'fullName': 'OcuNexus Therapeutics, Inc.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'NEX-OCU-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Nexagon™ or Nexagon™ vehicle']}], 'interventions': [{'name': 'Nexagon™ or Nexagon™ vehicle', 'type': 'DRUG', 'description': 'Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1001', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Eye Limited', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Sue Ormonde, MD, FRC Ophth, FRANZCO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Auckland Eye'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OcuNexus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Scott Bannan', 'oldOrganization': 'CoDaTherapeutics'}}}}