Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
26. maj 2015 opdateret af: Alcon Research
The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
142
Fase
- Ikke anvendelig
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:
- Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
- Symptoms of contact lens discomfort as defined by the protocol.
- Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
- Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Extended (over-night) contact lens wearer.
- Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
- Other protocol-specified exclusion criteria may apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Clear Care
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Andre navne:
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
|
|
Aktiv komparator: Habitual MPS
Habitual contact lens solution used with habitual contact lenses for 90 days
|
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
Biguanide-preserved
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
Tidsramme: Baseline (Day 0), Day 90
|
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae).
The maximum of the four zones was selected for the analysis.
Both eyes were included in the model for analysis.
A higher change value indicates a larger reduction in the severity of the lid papillae.
|
Baseline (Day 0), Day 90
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
Tidsramme: Day 90
|
As interpreted and reported by the subject on a questionnaire.
A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree.
The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.
|
Day 90
|
|
Mean Frequency Score for Symptoms of Grittiness at Day 90
Tidsramme: Day 90
|
As interpreted and reported by the subject on a questionnaire.
The subject was asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly).
|
Day 90
|
|
Mean Frequency Score for Symptoms of Dryness at Day 90
Tidsramme: Day 90
|
As reported and interpreted by the subject on a questionnaire.
The subject was asked "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly).
|
Day 90
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Lisa Zoota, MPH, Alcon Research
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. december 2013
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
18. november 2013
Først indsendt, der opfyldte QC-kriterier
22. november 2013
Først opslået (Skøn)
27. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. maj 2015
Sidst verificeret
1. maj 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A01337
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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