Clinical Evaluation of Fitting Investigational Contact Lenses
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Florida
-
Jacksonville, Florida, Spojené státy, 32256
- Vistakon Research Clinic
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
- The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
- The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
- The subject's distance spherical equivalent or spherical component (if fit with a toric lens) of their refraction must be in the range -1.25 D to -3.75 D in each eye.
- The subject's refractive cylinder must be 0.00 D to -1.50 D in at least one eye and no greater than -1.50 D in either eye.
- The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
- The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
- The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- The subject must have a wearable pair of spectacles if required for their distance vision.
Exclusion Criteria:
- Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
- Pregnancy or lactation.
- Currently diagnosed with diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
- Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
- A history of amblyopia, strabismus or binocular vision abnormality.
- Any ocular infection or inflammation.
- Any ocular abnormality that may interfere with contact lens wear.
- Use of any ocular medication, with the exception of rewetting drops.
- History of herpetic keratitis.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Employee of clinical site (e.g., Investigator, Coordinator, Technician)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: etafilcon A Toric Multifocal
|
Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50.
The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.
|
|
Aktivní komparátor: etafilcon A Multifocal
|
Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50.
The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The Average Number of Fitting Modifications to Optimize Vision
Časové okno: 15 minutes post lens insertion
|
The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed.
The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide.
Up to two modifications per subject was allowed.
The number of modifications required by the ECP to optimize vision was reported.
|
15 minutes post lens insertion
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Subject's Responses to Individual Item 1
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?".
This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied.
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 2
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?".
This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely.
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 3
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Please Think About Your Experience Today With The Study Contact Lenses.
Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?".
This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied.
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 4
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Where Would You Expect To Go Looking For Information About This Contact Lens?
Please Select All That Apply.".
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 5
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?".
This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never.
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 6
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "What Are Your Current Vision Correction Solutions?".
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 7
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Study Compare To Your Current Vision Correction Solutions?".
This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse.
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 8
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?".
This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited.
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 9
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "How would you rate your overall visual performance with the study contact lens?".
This item had a response set of Excellent, Very Good, Good, Fair and Poor.
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
|
Subject's Responses to Individual Item 10
Časové okno: 15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?".
This item had a response set of Excellent, Very Good, Good, Fair and Poor.
The percentage of subject's in each response category was reported.
|
15 Minuted Post Lens Insertion
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- CR-5913
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .