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Clinical Evaluation of Approved and Investigational Contact Lenses

Primary Purpose

Visual Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational Contact Lenses (Test)
Marketed Contact Lenses (Control)
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be between 18 to 40 years of age at the time of consent.
  • The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.
  • Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.
  • The subject must have best corrected visual acuity of 20/30 or better in each eye.
  • The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
  • The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  • Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
  • Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Sites / Locations

  • Golden Family Eyecare
  • Eye Associates of Winter Park
  • Pickens Family Eye Care
  • Total Eye Care PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 (Test Lens)

Arm 2 (Control Lens)

Arm Description

Subjects will be dispensed the Investigational Contact Lenses (Test) to be worn as daily wear.

Subjects will be dispensed the Marketed Contact Lenses (Control) to be worn as daily wear.

Outcomes

Primary Outcome Measures

Acceptable Lens Fitting
Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.
Overall Comfort
Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2016
Last Updated
May 4, 2017
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02669095
Brief Title
Clinical Evaluation of Approved and Investigational Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (Test Lens)
Arm Type
Experimental
Arm Description
Subjects will be dispensed the Investigational Contact Lenses (Test) to be worn as daily wear.
Arm Title
Arm 2 (Control Lens)
Arm Type
Active Comparator
Arm Description
Subjects will be dispensed the Marketed Contact Lenses (Control) to be worn as daily wear.
Intervention Type
Device
Intervention Name(s)
Investigational Contact Lenses (Test)
Other Intervention Name(s)
senofilcon C
Intervention Type
Device
Intervention Name(s)
Marketed Contact Lenses (Control)
Other Intervention Name(s)
comfilcon A
Primary Outcome Measure Information:
Title
Acceptable Lens Fitting
Description
Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.
Time Frame
Up to 4 Week Follow-up
Title
Overall Comfort
Description
Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.
Time Frame
Up to 4 Week Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be between 18 to 40 years of age at the time of consent. The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye. Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day. The subject must have best corrected visual acuity of 20/30 or better in each eye. The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes. The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study. The subject must have normal eyes (i.e., no ocular medications or infections of any type). Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.). Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Facility Information:
Facility Name
Golden Family Eyecare
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Eye Associates of Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Pickens Family Eye Care
City
Pickens
State/Province
South Carolina
ZIP/Postal Code
29671
Country
United States
Facility Name
Total Eye Care PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of Approved and Investigational Contact Lenses

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