Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-04-02 @ 8:47 AM
Study NCT ID:
NCT00642135
Status:
TERMINATED
Last Update Posted:
2008-04-10
First Post:
2008-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D015878', 'term': 'Mydriasis'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011681', 'term': 'Pupil Disorders'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'The total number of patients has been reached.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2008-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-09', 'studyFirstSubmitDate': '2008-03-17', 'studyFirstSubmitQcDate': '2008-03-21', 'lastUpdatePostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.', 'timeFrame': '75 minutes'}], 'secondaryOutcomes': [{'measure': 'Frequency of the nurse intervention to obtain the mydriasis', 'timeFrame': 'during 215 minutes maximum'}, {'measure': 'Calculation of the dose of active drugs administrated', 'timeFrame': 'one day'}, {'measure': 'Local and systemic clinical tolerance', 'timeFrame': 'one day'}, {'measure': 'Occurrence of adverse reactions', 'timeFrame': 'one day'}, {'measure': 'Stability of a mydriasis of good quality at T+195', 'timeFrame': 'at T+195 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['premature', 'neonates', 'infants', 'children', 'Mydriasert®', 'mydriasis', 'fundus', 'Tropicamide', 'Phenylephrine', 'clinical trial', 'Infant', 'premature newborns', 'bilateral diagnosis fundus'], 'conditions': ['Retinal Anomalies', 'Premature Birth']}, 'descriptionModule': {'briefSummary': 'Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. The fundus is essential to detect retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.', 'detailedDescription': 'The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature newborns, neonates and infants of less 18 months-old indoor in the neonatology clinical department of Robert Debre Hospital with cardiologic monitoring\n* Presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal and/or disk anomalies).\n* Needing a bilateral fundus\n* Parents, tutor or legal representing of the patient had been informed of objectives of the study and had given their written consent.\n* Covered by French social security or CMU\n\nExclusion Criteria:\n\n* Neonates of less 1000g at inclusion\n* Premature newborn of less 30 weeks of gestational age at inclusion\n* Contra-indication to one of the evaluated drugs\n* Any treatment that could provoke a dangerous drug interaction for the patient if associated with one of the drug of the study\n* Anatomical predisposition to glaucoma, hypertension or any other contra-indication noted by the physician'}, 'identificationModule': {'nctId': 'NCT00642135', 'briefTitle': 'CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Efficacy and Tolerance of Ophthalmic Insert Mydriasert® Versus Reference Treatment (Phenylephrine and Tropicamide Eyedrops) in Premature Newborns, Neonates and Infants Justifying a Mydriasis for a Bilateral Diagnosis Fundus', 'orgStudyIdInfo': {'id': 'P050308'}, 'secondaryIdInfos': [{'id': 'réf Afssaps : 437-050883-LB/GG'}, {'id': 'Eudract : 2005-004418-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops', 'interventionNames': ['Drug: phenylephrine and tropicamide eyedrops']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Premature newborns and neonates treated using insert Mydriasert®', 'interventionNames': ['Drug: Mydriasert®']}], 'interventions': [{'name': 'Mydriasert®', 'type': 'DRUG', 'description': 'Premature newborns and neonates treated using ophthalmologic insert Mydriasert®', 'armGroupLabels': ['2']}, {'name': 'phenylephrine and tropicamide eyedrops', 'type': 'DRUG', 'description': 'Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Dominique BREMOND GIGNAC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Robert Debré, APHP, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ioltech', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mathieu QUINTIN', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}