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Evaluation of an Investigational Multifocal Lens

18 juni 2018 bijgewerkt door: Johnson & Johnson Vision Care, Inc.
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

371

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Montgomery, Alabama, Verenigde Staten, 36109
    • California
      • Mission Viejo, California, Verenigde Staten, 92691
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32205
      • Jacksonville, Florida, Verenigde Staten, 32250
      • Orange Park, Florida, Verenigde Staten, 32065
      • Saint Augustine, Florida, Verenigde Staten, 32092
      • Tallahassee, Florida, Verenigde Staten, 32308
      • Tampa, Florida, Verenigde Staten, 33625
      • Winter Park, Florida, Verenigde Staten, 32792
    • Georgia
      • Roswell, Georgia, Verenigde Staten, 30076
    • Kansas
      • Pittsburg, Kansas, Verenigde Staten, 66762
    • Michigan
      • East Lansing, Michigan, Verenigde Staten, 48823
    • New York
      • Vestal, New York, Verenigde Staten, 13850
    • North Carolina
      • Denver, North Carolina, Verenigde Staten, 28037
    • Ohio
      • Powell, Ohio, Verenigde Staten, 43065
      • Springfield, Ohio, Verenigde Staten, 45503
    • Rhode Island
      • Warwick, Rhode Island, Verenigde Staten, 02888
    • Tennessee
      • Memphis, Tennessee, Verenigde Staten, 38119
    • Texas
      • Tyler, Texas, Verenigde Staten, 75701
    • Virginia
      • Salem, Virginia, Verenigde Staten, 24153

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Between 40 and 70 years of age.
  4. Subjects must own a wearable pair of spectacles, if required for their distance vision.
  5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)
  6. Already 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"*
  7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
  8. Refractive cylinder ≤ -0.75 D in each eye.
  9. ADD power in the range +0.75 D to +2.50 D in each eye.
  10. Best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
  2. Any ocular or systemic allergies that may have contraindicated contact lens wear.
  3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
  4. Any ocular abnormality that may have interfered with contact lens wear.
  5. Use of any ocular medication, with the exception of rewetting drops.
  6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  7. History of herpetic keratitis.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
  10. History of diabetes.
  11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
  13. Any ocular infection or inflammation.
  14. Any corneal distortion or irregular cornea.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: lotrafilcon B / etafilcon A
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
Apparaat: lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
Andere namen:
  • AirOptix Aqua multifocaal
Apparaat: etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.
Experimenteel: etafilcon A / lotrafilcon B
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
Apparaat: lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
Andere namen:
  • AirOptix Aqua multifocaal
Apparaat: etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
Tijdsspanne: 8 -12 days post wear
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
8 -12 days post wear
Distance Binocular Visual Acuity (LogMAR)
Tijdsspanne: 8- 12 Days post wear
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
8- 12 Days post wear
Intermediate Binocular Visual Acuity (LogMAR)
Tijdsspanne: 8-12 days post wear
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
8-12 days post wear
Near Binocular Visual Acuity (LogMAR)
Tijdsspanne: 8-12 days post wear
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
8-12 days post wear
Corneal Staining
Tijdsspanne: 8 - 12 Days post wear
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
8 - 12 Days post wear
Bulbar Conjunctival Injection
Tijdsspanne: 8- 12 Days post wear
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
8- 12 Days post wear
Limbal Conjunctival Injection
Tijdsspanne: 8- 12 Days post wear
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
8- 12 Days post wear
Contact Lens Fitting
Tijdsspanne: 8- 12 Days post wear
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
8- 12 Days post wear

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Johnson & Johnson Vision Care, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2014

Primaire voltooiing (Werkelijk)

1 november 2014

Studie voltooiing (Werkelijk)

1 november 2014

Studieregistratiedata

Eerst ingediend

20 augustus 2014

Eerst ingediend dat voldeed aan de QC-criteria

20 augustus 2014

Eerst geplaatst (Schatting)

22 augustus 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 juni 2018

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2018

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR-5593

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