Assessment of Daily Disposable Silicone Hydrogel Lens Wear

This study has been completed.
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01093625
First received: March 24, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.


Condition Intervention
Myopia
Device: Narafilcon B Contact Lens
Device: Spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Papillary Conjunctivitis [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  • Conjunctival Hyperemia [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  • Limbal Hyperemia [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  • Corneal Staining [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.

  • Conjunctival Staining [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  • Corneal Neovascularization [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  • Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.


Secondary Outcome Measures:
  • Comfortable Wearing Time [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.


Enrollment: 157
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Narafilcon B Contact Lens
Investigational Silicone Hydrogel Contact Lens
Device: Narafilcon B Contact Lens
Other Name: Investigational Silicone Hydrogel
Active Comparator: Spectacles Device: Spectacles
spectacle wearers

  Eligibility

Ages Eligible for Study:   15 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
  • Willing to comply with the study visit schedule.
  • Ages 15 to 39.
  • Has access to a cellular telephone with text messaging capabilities.
  • Has a current pair of spectacles.
  • 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
  • Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
  • Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
  • Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
  • They agree not to participate in other clinical research during the duration of this study.

Exclusion Criteria:

  • Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
  • Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
  • Systemic disease, which might interfere with contact lens wear.
  • Medication usage that may be associated with eye dryness.
  • Use of any topical medication such as eye drops or ointment.
  • Pregnant or lactating (by self-report).
  • Aphakia.
  • Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
  • Have participated in any other clinical trial or research in the two weeks prior to starting this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093625

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Vistakon
Ohio State University
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01093625     History of Changes
Other Study ID Numbers: CR-0916
Study First Received: March 24, 2010
Results First Received: October 30, 2013
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014