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Assessment of Daily Disposable Silicone Hydrogel Lens Wear

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narafilcon B Contact Lens
Spectacles
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

15 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Narafilcon B Contact Lens

Spectacles

Arm Description

Investigational Silicone Hydrogel Contact Lens

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 24, 2010
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT01093625
Brief Title
Assessment of Daily Disposable Silicone Hydrogel Lens Wear
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narafilcon B Contact Lens
Arm Type
Experimental
Arm Description
Investigational Silicone Hydrogel Contact Lens
Arm Title
Spectacles
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Narafilcon B Contact Lens
Other Intervention Name(s)
Investigational Silicone Hydrogel
Intervention Type
Device
Intervention Name(s)
Spectacles
Intervention Description
spectacle wearers
Primary Outcome Measure Information:
Title
Papillary Conjunctivitis
Description
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.
Time Frame
1 Year
Title
Conjunctival Hyperemia
Description
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.
Time Frame
1 Year
Title
Limbal Hyperemia
Description
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.
Time Frame
1 Year
Title
Corneal Staining
Description
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.
Time Frame
1 Year
Title
Conjunctival Staining
Description
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.
Time Frame
1 Year
Title
Corneal Neovascularization
Description
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.
Time Frame
1 Year
Title
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Comfortable Wearing Time
Description
Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Assessment of Daily Disposable Silicone Hydrogel Lens Wear

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