Back to resultsCLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
Primary Purpose
Retinal Anomalies, Premature Birth
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Mydriasert®
phenylephrine and tropicamide eyedrops
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Anomalies focused on measuring premature, neonates, infants, children, Mydriasert®, mydriasis, fundus, Tropicamide, Phenylephrine, clinical trial, Infant, premature newborns, bilateral diagnosis fundus
Eligibility Criteria
Inclusion Criteria:
- Premature newborns, neonates and infants of less 18 months-old indoor in the neonatology clinical department of Robert Debre Hospital with cardiologic monitoring
- Presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal and/or disk anomalies).
- Needing a bilateral fundus
- Parents, tutor or legal representing of the patient had been informed of objectives of the study and had given their written consent.
- Covered by French social security or CMU
Exclusion Criteria:
- Neonates of less 1000g at inclusion
- Premature newborn of less 30 weeks of gestational age at inclusion
- Contra-indication to one of the evaluated drugs
- Any treatment that could provoke a dangerous drug interaction for the patient if associated with one of the drug of the study
- Anatomical predisposition to glaucoma, hypertension or any other contra-indication noted by the physician
Sites / Locations
- Hôpital Robert Debré
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops
Premature newborns and neonates treated using insert Mydriasert®
Outcomes
Primary Outcome Measures
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
Secondary Outcome Measures
Frequency of the nurse intervention to obtain the mydriasis
Calculation of the dose of active drugs administrated
Local and systemic clinical tolerance
Occurrence of adverse reactions
Stability of a mydriasis of good quality at T+195
Full Information
NCT ID
NCT00642135
First Posted
March 17, 2008
Last Updated
April 9, 2008
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ioltech
1. Study Identification
Unique Protocol Identification Number
NCT00642135
Brief Title
CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Terminated
Why Stopped
The total number of patients has been reached.
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2008 (Anticipated)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ioltech
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Anomalies, Premature Birth
Keywords
premature, neonates, infants, children, Mydriasert®, mydriasis, fundus, Tropicamide, Phenylephrine, clinical trial, Infant, premature newborns, bilateral diagnosis fundus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops
Arm Title
2
Arm Type
Active Comparator
Arm Description
Premature newborns and neonates treated using insert Mydriasert®
Intervention Type
Drug
Intervention Name(s)
Mydriasert®
Intervention Description
Premature newborns and neonates treated using ophthalmologic insert Mydriasert®
Intervention Type
Drug
Intervention Name(s)
phenylephrine and tropicamide eyedrops
Intervention Description
Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)
Primary Outcome Measure Information:
Title
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
Time Frame
75 minutes
Secondary Outcome Measure Information:
Title
Frequency of the nurse intervention to obtain the mydriasis
Time Frame
during 215 minutes maximum
Title
Calculation of the dose of active drugs administrated
Time Frame
one day
Title
Local and systemic clinical tolerance
Time Frame
one day
Title
Occurrence of adverse reactions
Time Frame
one day
Title
Stability of a mydriasis of good quality at T+195
Time Frame
at T+195 minutes
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature newborns, neonates and infants of less 18 months-old indoor in the neonatology clinical department of Robert Debre Hospital with cardiologic monitoring
Presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal and/or disk anomalies).
Needing a bilateral fundus
Parents, tutor or legal representing of the patient had been informed of objectives of the study and had given their written consent.
Covered by French social security or CMU
Exclusion Criteria:
Neonates of less 1000g at inclusion
Premature newborn of less 30 weeks of gestational age at inclusion
Contra-indication to one of the evaluated drugs
Any treatment that could provoke a dangerous drug interaction for the patient if associated with one of the drug of the study
Anatomical predisposition to glaucoma, hypertension or any other contra-indication noted by the physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique BREMOND GIGNAC, MD
Organizational Affiliation
Hôpital Robert Debré, APHP, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
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CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
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