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

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ClinicalTrials.gov Identifier: NCT01791517
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : November 6, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

February 11, 2013
February 15, 2013
August 16, 2017
November 6, 2017
June 19, 2018
February 1, 2013
February 1, 2014   (Final data collection date for primary outcome measure)
  • 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).
Patient Reported Comfort using Contact Lens User Experience (CLUE) TM Comfort Domain [ Time Frame: 2 weeks post daily wear ]
Assessment The Contact Lens User Evaluation(CLUE)TM questionnaire 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).
Complete list of historical versions of study NCT01791517 on ClinicalTrials.gov Archive Site
Not Provided
  • Corneal Staining [ Time Frame: 2 weeks post daily wear ]
  • Limbal Conjunctival Redness [ Time Frame: 2 weeks post daily wear ]
  • Bulbar Conjunctival Redness [ Time Frame: 2 weeks post daily wear ]
  • Tarsal Appearance [ Time Frame: 2 weeks post daily wear ]
Not Provided
Not Provided
 
Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions
Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions
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).
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Contact Lens Solutions
  • 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 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)).
    Interventions:
    • Other: Solution 1 (Test)
    • Other: Solution 2 (Test)
    • Other: Solution 3 (Test)
    • Other: Solution 4 (Control)
  • 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)).
    Interventions:
    • Other: Solution 1 (Test)
    • Other: Solution 2 (Test)
    • Other: Solution 3 (Test)
    • Other: Solution 4 (Control)
  • 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)).
    Interventions:
    • Other: Solution 1 (Test)
    • Other: Solution 2 (Test)
    • Other: Solution 3 (Test)
    • Other: Solution 4 (Control)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
269
240
February 1, 2014
February 1, 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom,   United States
 
 
NCT01791517
CR-5230
No
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
Not Provided
Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc.
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP