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Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process

Primary Purpose

Refractive Error Correction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test/Control
Control/Test
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error Correction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
  4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
  5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
  7. The subject's refractive cylinder must be < 0.75 D in each eye.
  8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
  3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  4. Any ocular infection.
  5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  6. Monovision or multi-focal contact lens correction.
  7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
  10. Suspicion of or recent history of alcohol or substance abuse.
  11. History of serious mental illness.
  12. History of seizures.
  13. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

Sites / Locations

  • Total Eye Care, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CONTROL- etafilcon A current molding

TEST- etafilcon A novel molding

Arm Description

1-Day ACUVUE® MOIST

Investigational Contact Lens

Outcomes

Primary Outcome Measures

Overall Comfort Scores
Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Overall Vision Score
Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2018
Last Updated
August 13, 2019
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03605303
Brief Title
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process
Official Title
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated due to the released lenses not representing what will be made commercially available and thus the objectives could not be met
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error Correction

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CONTROL- etafilcon A current molding
Arm Type
Active Comparator
Arm Description
1-Day ACUVUE® MOIST
Arm Title
TEST- etafilcon A novel molding
Arm Type
Experimental
Arm Description
Investigational Contact Lens
Intervention Type
Device
Intervention Name(s)
Test/Control
Intervention Description
Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments
Intervention Type
Device
Intervention Name(s)
Control/Test
Intervention Description
Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments
Primary Outcome Measure Information:
Title
Overall Comfort Scores
Description
Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time Frame
1-Week Follow-up
Title
Overall Vision Score
Description
Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time Frame
1-Week Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear). The subject must have normal eyes (i.e., no ocular medications or infections of any type). The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye. The subject's refractive cylinder must be < 0.75 D in each eye. The subject must have best corrected visual acuity of 20/25 or better in each eye. Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Monovision or multi-focal contact lens correction. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. History of binocular vision abnormality or strabismus. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report). Suspicion of or recent history of alcohol or substance abuse. History of serious mental illness. History of seizures. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
Facility Information:
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process

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