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Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791517
First Posted: February 15, 2013
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  Purpose
The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).

Condition Intervention
Contact Lens Solutions Other: Solution 1 (Test) Other: Solution 2 (Test) Other: Solution 3 (Test) Other: Solution 4 (Control)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Overall Comfort Score (Senofilcon A Lens) [ Time Frame: 2-Week Follow-up ]
    CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

  • Overall Comfort Score (Galyfilcon A Lens) [ Time Frame: 2-Week Follow-up ]
    CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

  • Overall Comfort Score (Etafilcon A Lens) [ Time Frame: 2-Week Follow-up ]
    CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3XSD).


Enrollment: 269
Actual Study Start Date: February 1, 2013
Study Completion Date: February 1, 2014
Primary Completion Date: February 1, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lens A (senofilcon A)
Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
Other: Solution 1 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Other Name: Revitalens
Other: Solution 2 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Pure Moist
Other: Solution 3 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Biotrue
Other: Solution 4 (Control)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Clear Care
Lens B (galyfilcon A)
Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
Other: Solution 1 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Other Name: Revitalens
Other: Solution 2 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Pure Moist
Other: Solution 3 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Biotrue
Other: Solution 4 (Control)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Clear Care
Lens C (etafilcon A)
Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
Other: Solution 1 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Other Name: Revitalens
Other: Solution 2 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Pure Moist
Other: Solution 3 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Biotrue
Other: Solution 4 (Control)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Other Name: Clear Care

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol.
  3. The subject must be between 18 and 69 years of age.
  4. The subject must be willing to participate in a 9-month study.
  5. The subject must require a visual correction in both eyes.
  6. Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.
  7. The subject must have best-corrected visual acuity of 0.20 or better in each eye.
  8. The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
  9. The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.
  10. The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.

Exclusion Criteria:

  1. Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).
  2. Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
  3. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
  4. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
  5. Any active ocular infection.
  6. Current use of topical ophthalmic medications.
  7. History of binocular vision abnormality or strabismus.
  8. More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).
  9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
  10. History of severe allergic reaction or anaphylaxis.
  11. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
  12. Employee of the investigational clinic (e.g. investigator, coordinator, technician)
  13. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791517


Locations
United States, Texas
University of Houston College of Optometry
Houston, Texas, United States, 77204
Canada, Ontario
University of Waterloo Centre for Contact Lens Research School of Optometry
Waterloo, Ontario, Canada
United Kingdom
University of Manchester, Department of Optometry & Neuroscience
Manchester, Lancashire, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01791517     History of Changes
Other Study ID Numbers: CR-5230
First Submitted: February 11, 2013
First Posted: February 15, 2013
Results First Submitted: August 16, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Pharmaceutical Solutions
Contact Lens Solutions
Disinfectants
Anti-Infective Agents