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Clinical Evaluation of Two Monthly Contact Lenses

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ClinicalTrials.gov Identifier: NCT03459131
Recruitment Status : Completed
First Posted : March 8, 2018
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE March 8, 2018
Results First Submitted Date  ICMJE February 13, 2019
Results First Posted Date  ICMJE March 5, 2019
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE March 7, 2018
Actual Primary Completion Date March 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
Subjective Rating of Overall Vision [ Time Frame: Day 7, each product ]
Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
Subjective Rating of Overall Vision [ Time Frame: Day 7, each product ]
Overall vision will be assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent.
Change History Complete list of historical versions of study NCT03459131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
Over-refraction [ Time Frame: Day 1 (Dispense), each product ]
Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
Over-refraction [ Time Frame: Day 1 (Dispense), each product ]
Over-refraction (amount of additional correction needed to improve visual acuity (VA)) will be collected for each eye and measured in diopters.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Two Monthly Contact Lenses
Official Title  ICMJE Clinical Evaluation of Two Monthly Contact Lenses
Brief Summary The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Refractive Errors
Intervention  ICMJE
  • Device: Comfilcon A with Digital Zone Optics™ contact lenses
    Silicone hydrogel spherical contact lenses with Digital Zone Optics™
    Other Name: BIOFINITY® ENERGYS™
  • Device: Comfilcon A contact lenses
    Silicone hydrogel spherical contact lenses
    Other Name: BIOFINITY®
Study Arms  ICMJE
  • BIOFINITY ENERGYS then BIOFINITY
    Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
    Interventions:
    • Device: Comfilcon A with Digital Zone Optics™ contact lenses
    • Device: Comfilcon A contact lenses
  • BIOFINITY then BIOFINITY ENERGYS
    Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
    Interventions:
    • Device: Comfilcon A with Digital Zone Optics™ contact lenses
    • Device: Comfilcon A contact lenses
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 26, 2018
Actual Primary Completion Date March 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to understand and sign an approved informed consent form (ICF);
  • Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
  • Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
  • Refractive, ocular, or intraocular surgery, as specified in the protocol;
  • Current or history of eye injury or disorders, as specified in the protocol;
  • Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
  • Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
  • Use of topical ocular medications that would require instillation during contact lens wear;
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03459131
Other Study ID Numbers  ICMJE CLD523-E001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alcon, A Novartis Division Alcon, A Novartis Division
PRS Account Alcon Research
Verification Date February 2019

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