Assessment of Daily Disposable Silicone Hydrogel Lens Wear

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Narafilcon B Contact Lens; Device: Spectacles

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Narafilcon B Contact Lens; Investigational Silicone Hydrogel Contact Lens	Device: Narafilcon B Contact Lens; Other Names: Investigational Silicone Hydrogel
Active Comparator: Spectacles	Device: Spectacles; spectacle wearers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Papillary Conjunctivitis	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.	1 Year
Conjunctival Hyperemia	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.	1 Year
Limbal Hyperemia	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.	1 Year
Corneal Staining	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.	1 Year
Conjunctival Staining	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.	1 Year
Corneal Neovascularization	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.	1 Year
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire	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.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfortable Wearing Time	Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.	1 Year

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Ohio State University

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-0916