Safety Evaluation of a New Preservative in a Lubricating Eye Drop
13 september 2011 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
44
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Massachusetts
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Andover, Massachusetts, Förenta staterna, 01810
- ORA, Inc.
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
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Experimentell: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Post-dose Product Comfort
Tidsram: 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
Tidsram: 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
|
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Change from Baseline in Pre-dose Inferior Staining
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline, Within Two Weeks
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Pre-dose Nasal Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
|
Change from Baseline in Pre-Dose Average Staining
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline, Within Two Weeks
|
Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points
|
baseline, Within Two Weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Sherryl Frisch, Johnson & Johnson Consumer and Personal Products Worldwide
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2011
Primärt slutförande (Faktisk)
1 april 2011
Avslutad studie (Faktisk)
1 april 2011
Studieregistreringsdatum
Först inskickad
13 september 2011
Först inskickad som uppfyllde QC-kriterierna
13 september 2011
Första postat (Uppskatta)
14 september 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
14 september 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 september 2011
Senast verifierad
1 september 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UNKEDI0003
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