Retinal AnomaliesPhase 3NCT00642135
CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
A Phase 3 study testing Mydriasert® and phenylephrine and tropicamide eyedrops in people with Retinal Anomalies and Premature Birth, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Retinal Anomalies, Premature Birth
- What is being tested?
- Mydriasert® and phenylephrine and tropicamide eyedrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Retinal Anomalies, Premature Birth
- Being tested
- Mydriasert®, phenylephrine and tropicamide eyedrops
- Keywords
- premature, neonates, infants, children, Mydriasert®, mydriasis, fundus, Tropicamide, Phenylephrine, clinical trial, Infant, premature newborns, bilateral diagnosis fundus
- Medical subject headings
- Premature Birth, Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mydriasert®Drug
Premature newborns and neonates treated using ophthalmologic insert Mydriasert®
phenylephrine and tropicamide eyedropsDrug
Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops Receives: Drug: phenylephrine and tropicamide eyedrops |
| 2 | Active comparator | Premature newborns and neonates treated using insert Mydriasert® Receives: Drug: Mydriasert® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
Measured: 75 minutes
Secondary outcomes (5)
Frequency of the nurse intervention to obtain the mydriasis
Measured: during 215 minutes maximum
Calculation of the dose of active drugs administrated
Measured: one day
Local and systemic clinical tolerance
Measured: one day
Occurrence of adverse reactions
Measured: one day
Stability of a mydriasis of good quality at T+195
Measured: at T+195 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJan 2006
- Primary completionFeb 2008 (estimated)
- Study completionJun 2008 (estimated)
Why it stopped: The total number of patients has been reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal AnomaliesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ioltech
- Investigators
- Dominique BREMOND GIGNAC, MD, Principal investigator, Hôpital Robert Debré, APHP, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642135
- Sponsor's protocol ID
- P050308
- Other IDs
- réf Afssaps : 437-050883-LB/GG, Eudract : 2005-004418-33
- Status last verified
- Jan 2006
- First submitted
- 17 Mar 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00642135
- Acronym / sponsor ID
- P050308
- Conditions
- Retinal Anomalies, Premature Birth
- Keywords
- premature, neonates, infants, children, Mydriasert®, mydriasis, fundus, Tropicamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The total number of patients has been reached.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ioltech
- Study start
- Jan 2006
- Primary completion
- Feb 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: phenylephrine and tropicamide eyedropsPremature newborns and neonates treated using Phenylephrine and tropicamide eyedrops |
| 2 | Active comparator | Drug: Mydriasert®Premature newborns and neonates treated using insert Mydriasert® |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mydriasert®Premature newborns and neonates treated using ophthalmologic insert Mydriasert® | Drug | 2 |
| phenylephrine and tropicamide eyedropsPremature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops) | Drug | 1 |
Primary outcome
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
Time frame: 75 minutes
5 secondary outcomes
Frequency of the nurse intervention to obtain the mydriasis
Time frame: during 215 minutes maximum
Calculation of the dose of active drugs administrated
Time frame: one day
Local and systemic clinical tolerance
Time frame: one day
Occurrence of adverse reactions
Time frame: one day
Stability of a mydriasis of good quality at T+195
Time frame: at T+195 minutes
Results and safety
The study was stopped early (reason given: The total number of patients has been reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique BREMOND GIGNAC, MD principal investigator
Hôpital Robert Debré, APHP, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mydriasert® and phenylephrine and tropicamide eyedrops in people with Retinal Anomalies and Premature Birth, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The total number of patients has been reached.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus. (time frame: 75 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008; AzTrials last refreshed its copy on 6 Nov 2026.