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- Klinische proef NCT01526902
Proclear 1-D Multifocal Nondispensing Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Indiana
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Bloomington,, Indiana, Verenigde Staten, 47405
- Clinical Optics Research Lab, Indiana University,
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Be between 40 and 65 years of age (inclusive)
- Require a reading addition of +1.25 to +2.50D (inclusive)
- Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
- Spectacle cylinder less than or equal to 0.75D in both eyes.
- Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
- Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
- Have a minimum 2 weeks soft contact lens experience
- Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
- Able to read, comprehend and sign an informed consent
- Willing to comply with the wear and study visit schedule
- Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
- No gas permeable contact lens wear for 1 month prior to the study
Exclusion Criteria:
To be eligible for the study, each candidate must not present with any of the following
- Any active corneal infection, injury, inflammation, or ocular abnormality
- Systemic or ocular allergies, which might interfere with contact lens wear
- Systemic disease, which might interfere with contact lens wear
- Ocular disease, which might interfere with contact lens wear
- Pregnant or lactating
- Strabismus/amblyopia
- Habitually uncorrected anisometropia greater than or equal to 2.00 D
- Subjects who have undergone corneal refractive surgery
- Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: omafilcon A / PC 1-D MF
omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF) Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. |
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
Andere namen:
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses
Andere namen:
|
Actieve vergelijker: lotrafilcon B / Air Optix MF
lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF) Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. |
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
Andere namen:
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Objective Vision Assessments: High Contrast Distance Visual Acuity
Tijdsspanne: After 1 hour of lens wear
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Tested with charts distant to the subject with both eyes together in normal lighting conditions.
The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity.
Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
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After 1 hour of lens wear
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Objective Vision Assessments: High Contrast Intermediate Visual Acuity
Tijdsspanne: After 1 hour of lens wear
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Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions.
The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity.
Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
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After 1 hour of lens wear
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Objective Vision Assessments: High Contrast Near Visual Acuity
Tijdsspanne: After 1 hour of lens wear
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Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions.
The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity.
Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
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After 1 hour of lens wear
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Subjective Overall Vision: High Contrast Distance Visual Quality
Tijdsspanne: After 1 hour of lens wear
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Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
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After 1 hour of lens wear
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Subjective Vision Assessments: High Contrast Intermediate Visual Quality
Tijdsspanne: After 1 hour of lens wear
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Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
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After 1 hour of lens wear
|
Subjective Vision Assessments: High Contrast Near Visual Quality
Tijdsspanne: After 1 hour of lens wear
|
Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
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After 1 hour of lens wear
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Peter Kollbaum, OD, PhD, Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CV-12-02A
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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