Safety Evaluation of a New Preservative in a Lubricating Eye Drop
13 september 2011 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
44
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Massachusetts
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Andover, Massachusetts, Verenigde Staten, 01810
- ORA, Inc.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Healthy Subjects
Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.
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Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42
Andere namen:
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Experimenteel: 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.
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Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Post-dose Product Comfort
Tijdsspanne: baseline, Within Two weeks
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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.
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baseline, Within Two weeks
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Change from Baseline in Pre-Dose Visual Acuity
Tijdsspanne: baseline, Within Two weeks
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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.)
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baseline, Within Two weeks
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Change from Baseline in Pre-dose Inferior Staining
Tijdsspanne: baseline, Within Two weeks
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Means and Differences from Visit 1 in Pre-Dose Inferior Staining
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baseline, Within Two weeks
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Change from Baseline in Mean Corneal Staining
Tijdsspanne: baseline, Within Two Weeks
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Mean Corneal Staining averaging over the 5 corneal regions and averaging over both eyes (NEI scale 0-3)
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baseline, Within Two Weeks
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Change from Baseline in Pre-Dose Central Staining
Tijdsspanne: baseline, Within Two Weeks
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Pre-dose Central Staining: Means and Differences from Visit 1
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baseline, Within Two Weeks
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Change from Baseline in Pre-Dose Superior Staining
Tijdsspanne: baseline, Within Two Weeks
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Pre-Dose Superior Staining: Means and Differences from Visit 1
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baseline, Within Two Weeks
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Change from Baseline in Pre-Dose Temporal Staining
Tijdsspanne: baseline, Within Two Weeks
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Pre-dose Temporal Staining: Means and Differences from Visit 1
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baseline, Within Two Weeks
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Change from Baseline in Pre-Dose Nasal Staining
Tijdsspanne: baseline, Within Two Weeks
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Pre-dose Nasal Staining: Means and Differences from Visit 1
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baseline, Within Two Weeks
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Change from Baseline in Pre-Dose Average Staining
Tijdsspanne: baseline, Within Two Weeks
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Pre-dose Average Staining: Means and Differences from Visit 1
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baseline, Within Two Weeks
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Changes in Slit-Lamp Findings: Eye Structure: Lid
Tijdsspanne: Within Two Weeks
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Slit-lamp findings were recorded for the Lid ocular structure at 6 time points
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Within Two Weeks
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Changes in Slit-Lamp Findings: Eye Structure: Lens
Tijdsspanne: baseline, Within Two Weeks
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Slit-lamp findings were recorded for the Lens ocular structure at 6 time points
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baseline, Within Two Weeks
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Changes in Slit-Lamp Findings: Eye Structure: Conjunctiva
Tijdsspanne: baseline, Within Two Weeks
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Slit-lamp findings were recorded for the Conjunctiva ocular structure at 6 time points
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baseline, Within Two Weeks
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Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea
Tijdsspanne: baseline, Within Two Weeks
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Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points
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baseline, Within Two Weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Sherryl Frisch, Johnson & Johnson Consumer and Personal Products Worldwide
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2011
Primaire voltooiing (Werkelijk)
1 april 2011
Studie voltooiing (Werkelijk)
1 april 2011
Studieregistratiedata
Eerst ingediend
13 september 2011
Eerst ingediend dat voldeed aan de QC-criteria
13 september 2011
Eerst geplaatst (Schatting)
14 september 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
14 september 2011
Laatste update ingediend die voldeed aan QC-criteria
13 september 2011
Laatst geverifieerd
1 september 2011
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UNKEDI0003
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