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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014