Safety Evaluation of a New Preservative in a Lubricating Eye Drop
13 septembre 2011 mis à jour par: Johnson & Johnson Consumer and Personal Products Worldwide
A Single-Center Study Evaluating the Safety of a New Preservative in an OTC Lubricant Eye Drop Used QID in Healthy Adults and in Subjects Diagnosed With Dry Eye
This study is to evaluate the safety of a new preservative in a lubricant eye drop used four times a day in healthy adults and subjects diagnosed with dry eye.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Single-site, open-labeled study.
Twenty two subjects will be enrolled into the healthy adult group and twenty two subjects into the dry eye group.
Each subject will be in the study for approximately 2 weeks (treatment) and seen at three study Visits: Visit 1 (Day 0, Baseline), Visit 2 (Day 7 +/- 1) and Visit 3 (Day 14 +/- 1).
Dosing regimen is 1-2 drops into each eye, four times daily, for two weeks.
Assessments will be comprised of visual acuity, slit lamp biomicroscopy, fluorescein corneal staining, and product comfort.
Type d'étude
Interventionnel
Inscription (Réel)
44
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Massachusetts
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Andover, Massachusetts, États-Unis, 01810
- ORA, Inc.
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- At least 18 years of age
- Able to follow all study instructions and attend all required study visits
- Provide written informed consent
- Visual health and eye comfort within protocol-specified parameters
- Women of child-bearing potential must have a negative urine pregnancy test at screening, not be breast-feeding, and agree to use a protocol-specified acceptable form of birth control throughout the study
Exclusion Criteria:
- Any medical condition or history, or ocular scores, or use of any drug, device or medication that, per protocol or in the opinion of the investigator, might compromise the safety of the subject or analysis of the study results.
- Use of contact lenses outside protocol allowance
- Self-reported pregnancy, positive urine pregnancy test, breast-feeding; intends to become pregnant or breast-feed during the duration of the study, refuses protocol-specified urine pregnancy testing, and/or does not use protocol-specified birth control methods and agree to continue doing so for the duration of the study.
- Participated in an investigational drug or device trial within 30 days of entering the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Healthy Subjects
Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.
|
Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42
Autres noms:
|
|
Expérimental: Dry-Eye Subjects
Dry-Eye Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.
|
Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post-dose Product Comfort
Délai: baseline, Within Two weeks
|
Product (ocular) comfort was assessed for each eye immediately, and at 1, 2, and 3 minutes following dosing at Visit 1 and 3 using a scale ranging from 0 to 10, where 0 is very uncomfortable and 10 is very comfortable.
|
baseline, Within Two weeks
|
|
Change from Baseline in Pre-Dose Visual Acuity
Délai: baseline, Within Two weeks
|
Change from Baseline in Pre-Treatment Means of Pre-Dose Visual Acuity on the LogMAR scale.
(The LogMAR scale converts the geometric sequence of a traditional chart to a linear scale.
It measures visual acuity loss; positive values indicate vision loss, while negative values denote normal or better visual acuity.)
|
baseline, Within Two weeks
|
|
Change from Baseline in Pre-dose Inferior Staining
Délai: baseline, Within Two weeks
|
Means and Differences from Visit 1 in Pre-Dose Inferior Staining
|
baseline, Within Two weeks
|
|
Change from Baseline in Mean Corneal Staining
Délai: baseline, Within Two Weeks
|
Mean Corneal Staining averaging over the 5 corneal regions and averaging over both eyes (NEI scale 0-3)
|
baseline, Within Two Weeks
|
|
Change from Baseline in Pre-Dose Central Staining
Délai: baseline, Within Two Weeks
|
Pre-dose Central Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
|
Change from Baseline in Pre-Dose Superior Staining
Délai: baseline, Within Two Weeks
|
Pre-Dose Superior Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
|
Change from Baseline in Pre-Dose Temporal Staining
Délai: baseline, Within Two Weeks
|
Pre-dose Temporal Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
|
Change from Baseline in Pre-Dose Nasal Staining
Délai: baseline, Within Two Weeks
|
Pre-dose Nasal Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
|
Change from Baseline in Pre-Dose Average Staining
Délai: baseline, Within Two Weeks
|
Pre-dose Average Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
|
Changes in Slit-Lamp Findings: Eye Structure: Lid
Délai: Within Two Weeks
|
Slit-lamp findings were recorded for the Lid ocular structure at 6 time points
|
Within Two Weeks
|
|
Changes in Slit-Lamp Findings: Eye Structure: Lens
Délai: baseline, Within Two Weeks
|
Slit-lamp findings were recorded for the Lens ocular structure at 6 time points
|
baseline, Within Two Weeks
|
|
Changes in Slit-Lamp Findings: Eye Structure: Conjunctiva
Délai: baseline, Within Two Weeks
|
Slit-lamp findings were recorded for the Conjunctiva ocular structure at 6 time points
|
baseline, Within Two Weeks
|
|
Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea
Délai: baseline, Within Two Weeks
|
Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points
|
baseline, Within Two Weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: Sherryl Frisch, Johnson & Johnson Consumer and Personal Products Worldwide
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2011
Achèvement primaire (Réel)
1 avril 2011
Achèvement de l'étude (Réel)
1 avril 2011
Dates d'inscription aux études
Première soumission
13 septembre 2011
Première soumission répondant aux critères de contrôle qualité
13 septembre 2011
Première publication (Estimation)
14 septembre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 septembre 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 septembre 2011
Dernière vérification
1 septembre 2011
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UNKEDI0003
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