Safety Evaluation of a New Preservative in a Lubricating Eye Drop
13. september 2011 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
44
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Massachusetts
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Andover, Massachusetts, Forente stater, 01810
- ORA, Inc.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
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Eksperimentell: 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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Post-dose Product Comfort
Tidsramme: 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.
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baseline, Within Two weeks
|
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Change from Baseline in Pre-Dose Visual Acuity
Tidsramme: 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.)
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baseline, Within Two weeks
|
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Change from Baseline in Pre-dose Inferior Staining
Tidsramme: baseline, Within Two weeks
|
Means and Differences from Visit 1 in Pre-Dose Inferior Staining
|
baseline, Within Two weeks
|
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Change from Baseline in Mean Corneal Staining
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline, Within Two Weeks
|
Pre-Dose Superior Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
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Change from Baseline in Pre-Dose Temporal Staining
Tidsramme: baseline, Within Two Weeks
|
Pre-dose Temporal Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
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Change from Baseline in Pre-Dose Nasal Staining
Tidsramme: baseline, Within Two Weeks
|
Pre-dose Nasal Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
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Change from Baseline in Pre-Dose Average Staining
Tidsramme: baseline, Within Two Weeks
|
Pre-dose Average Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
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Changes in Slit-Lamp Findings: Eye Structure: Lid
Tidsramme: Within Two Weeks
|
Slit-lamp findings were recorded for the Lid ocular structure at 6 time points
|
Within Two Weeks
|
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Changes in Slit-Lamp Findings: Eye Structure: Lens
Tidsramme: baseline, Within Two Weeks
|
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
Tidsramme: baseline, Within Two Weeks
|
Slit-lamp findings were recorded for the Conjunctiva ocular structure at 6 time points
|
baseline, Within Two Weeks
|
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Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea
Tidsramme: baseline, Within Two Weeks
|
Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points
|
baseline, Within Two Weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Sherryl Frisch, Johnson & Johnson Consumer and Personal Products Worldwide
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2011
Primær fullføring (Faktiske)
1. april 2011
Studiet fullført (Faktiske)
1. april 2011
Datoer for studieregistrering
Først innsendt
13. september 2011
Først innsendt som oppfylte QC-kriteriene
13. september 2011
Først lagt ut (Anslag)
14. september 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. september 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. september 2011
Sist bekreftet
1. september 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UNKEDI0003
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