- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01583868
A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
29. september 2020 opdateret af: Bausch & Lomb Incorporated
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb.
The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
216
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
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Rochester, New York, Forenede Stater, 14609
- Bausch & Lomb Incorporated
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye.
- Must agree to wear the study lenses on a daily wear basis for the duration of the study.
- Must be willing to use a lens care system on a regular basis.
- If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.
Exclusion Criteria:
- Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- Have an active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Anisometropia (spherical equivalent) of greater than 2.00 D.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Aphakic.
- Amblyopic.
- Allergic to any component in the study products.
- Have had any corneal surgery (ie, refractive surgery).
- Currently wear monovision correction, multifocal, or toric contact lenses.
- Ocular astigmatism greater than 1.00 D in either eye.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: B&L RD2135-01 lens C
Investigational Silicone hydrogel soft contact lens
|
Lenses will be worn on a daily wear basis for 1 week.
Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses.
Rewetting drops will be provided for use as needed during the study.
|
|
Eksperimentel: B&L RD2135-01 lens D
Investigational Silicone hydrogel soft contact lens
|
Lenses will be worn on a daily wear basis for 1 week.
Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses.
Rewetting drops will be provided for use as needed during the study.
|
|
Aktiv komparator: PureVision2
Bausch & Lomb High definition soft contact lenses
|
Lenses will be worn on a daily wear basis for 1 week.
Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses.
Rewetting drops will be provided for use as needed during the study.
|
|
Aktiv komparator: Ciba Vision Air Optix Aqua
Ciba Vision Air Optix Aqua soft contact lens
|
Lenses will be worn on a daily wear basis for 1 week.
Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses.
Rewetting drops will be provided for use as needed during the study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Synsstyrke
Tidsramme: Efter 1 uges opfølgning
|
Synsstyrken blev vurderet ved afstandshøjkontrastlogaritme af den minimale opløsningsvinkel (logMAR).
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Efter 1 uges opfølgning
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Symptoms and Complaints
Tidsramme: At 1 Week follow up
|
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period.
Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression.
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At 1 Week follow up
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2012
Primær færdiggørelse (Faktiske)
1. juni 2012
Studieafslutning (Faktiske)
1. juli 2012
Datoer for studieregistrering
Først indsendt
23. april 2012
Først indsendt, der opfyldte QC-kriterier
23. april 2012
Først opslået (Skøn)
24. april 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 755E
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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