- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00642135
CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
April 9, 2008 updated by: Assistance Publique - Hôpitaux de Paris
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75019
- Hôpital Robert Debré
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops
|
Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)
|
Active Comparator: 2
Premature newborns and neonates treated using insert Mydriasert®
|
Premature newborns and neonates treated using ophthalmologic insert Mydriasert®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
Time Frame: 75 minutes
|
75 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of the nurse intervention to obtain the mydriasis
Time Frame: during 215 minutes maximum
|
during 215 minutes maximum
|
Calculation of the dose of active drugs administrated
Time Frame: one day
|
one day
|
Local and systemic clinical tolerance
Time Frame: one day
|
one day
|
Occurrence of adverse reactions
Time Frame: one day
|
one day
|
Stability of a mydriasis of good quality at T+195
Time Frame: at T+195 minutes
|
at T+195 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dominique BREMOND GIGNAC, MD, Hôpital Robert Debré, APHP, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Anticipated)
February 1, 2008
Study Completion (Anticipated)
June 1, 2008
Study Registration Dates
First Submitted
March 17, 2008
First Submitted That Met QC Criteria
March 21, 2008
First Posted (Estimate)
March 24, 2008
Study Record Updates
Last Update Posted (Estimate)
April 10, 2008
Last Update Submitted That Met QC Criteria
April 9, 2008
Last Verified
January 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Premature Birth
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Pharmaceutical Solutions
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Ophthalmic Solutions
- Phenylephrine
- Oxymetazoline
- Tropicamide
Other Study ID Numbers
- P050308
- réf Afssaps : 437-050883-LB/GG
- Eudract : 2005-004418-33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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