CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert... | NCT00642135

Studies
CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment

NCT00642135

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

Apr 10, 2008Estimated

Enrollment

80Actual

Phase

Phase 3

Conditions

Retinal Anomalies
Premature Birth

Interventions

Mydriasert®
phenylephrine and tropicamide eyedrops

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The total number of patients has been reached.

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Feb 2008Estimated

Completion Date

Jun 2008Estimated

First Submitted Date

Mar 17, 2008

First Submission Date that Met QC Criteria

Mar 21, 2008

First Posted Date

Mar 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2008

Last Update Posted Date

Apr 10, 2008Estimated

Name	Class
Ioltech	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops	Drug: phenylephrine and tropicamide eyedrops
2	Active Comparator	Premature newborns and neonates treated using insert Mydriasert®	Drug: Mydriasert®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mydriasert®	Drug	Premature newborns and neonates treated using ophthalmologic insert Mydriasert®	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.		75 minutes

Secondary Outcomes

Measure	Description	Time Frame
Frequency of the nurse intervention to obtain the mydriasis		during 215 minutes maximum
Calculation of the dose of active drugs administrated		one day
Local and systemic clinical tolerance

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique BREMOND GIGNAC, MD	Hôpital Robert Debré, APHP, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Robert Debré		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D015878	Mydriasis

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010656	Phenylephrine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
réf Afssaps : 437-050883-LB/GG
Eudract : 2005-004418-33