- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00560898
Comparison of Two Multi-Purpose Solution and Lens Material Combinations on Corneal Barrier Function
19. mai 2008 oppdatert av: Southern California College of Optometry at Marshall B. Ketchum University
Comparison of Two Multi-Purpose Solution and Contact Lens Material Combinations on Human Corneal Barrier Function
The purpose of this study is to measure the relative "barrier" function of the top layer of the cornea (called the epithelium), or the degree to which the cornea can prevent the penetration of the colored dye sodium fluorescein into the eye.
This is a clinical investigation of the effect on corneal barrier function following wear of two contact lens materials and two contact lens care systems, approved for marketing in the US by the Food and Drug Administration.
These contact lenses will be worn for two hours, following soak in one of two marketed contact lens disinfecting solutions.
Approximately 25 young, adapted contact lens wearers will participate.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
- Legemiddel: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution
- Legemiddel: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution
- Legemiddel: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution
- Legemiddel: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution
Studietype
Intervensjonell
Registrering (Forventet)
25
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Fullerton, California, Forente stater, 92831
- Southern California College of Optometry
-
-
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 til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
At least 18 years of age.
- Understand your rights as a research subject and give written informed consent by signing the Informed Consent Form, Subject Bill of Rights, and Patient Authorization for Use and Release of Health and Research Study Information (HIPAA form).
- Be likely to finish the entire study, understand the study instructions, and be willing to follow the instructions.
- Contact lens prescription between +4.00 D to -9.00 D (spherical equivalent).
- Best correctable visual acuity of at least 20/40 in each eye.
- Willing to de-adapt (do not wear) from habitual contact lenses for periods of three days prior to barrier function determination.
- Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and barrier function determination periods.
- No known ocular or systemic allergies, which may interfere with contact lens wear.
- No known systemic disease, or need for medication that may interfere with contact lens wear (i.e. antihistamines, beta-blockers, steroids).
Exclusion Criteria:
Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
- Eye (ocular) or systemic allergies that may interfere with contact lens wear.
- Less than one month successful, full time (defined as more than 8 hours per day, and more than 5 days per week) soft lens wear.
- Systemic disease or uses of medication, which may interfere with contact lens wear.
- Clinically significant corneal swelling (greater than grade 3 or 4 on a 0-4 scale), corneal blood vessel growth) (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
- Any active ocular infection.
- Prior corneal refractive surgery (i.e., LASIK, PRK, etc).
- Have used medications within 24 hours of study entry or have an ongoing need to use ocular medication.
- Are taking part in any other study or have taken part in a study within the last 14 days
- Have a medical condition that your study eye doctor thinks may make it not appropriate for you to participate in this study.
- Are pregnant, or anticipate becoming pregnant during the course of this study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 2
contact lenses disinfected in multipurpose solution
|
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
Eksperimentell: 3
contact lenses disinfected in multipurpose solution
|
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
Eksperimentell: 4
contact lenses disinfected in multipurpose solution
|
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
Eksperimentell: 1
contact lenses disinfected in multipurpose solution
|
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Epithelial penetration rate of sodium fluoeescein, in nm/sec
Tidsramme: Immediately post measurement
|
Immediately post measurement
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Corneal staining
Tidsramme: Immediately following barrier determination
|
Immediately following barrier determination
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
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. september 2007
Primær fullføring (Faktiske)
1. desember 2007
Studiet fullført (Faktiske)
1. mars 2008
Datoer for studieregistrering
Først innsendt
15. november 2007
Først innsendt som oppfylte QC-kriteriene
19. november 2007
Først lagt ut (Anslag)
20. november 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. mai 2008
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2008
Sist bekreftet
1. mai 2008
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 00001418
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