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A Safety and Effectiveness Study of a New Multi-Purpose Contact Lens Care Solution

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.
 
ClinicalTrials.gov Identifier: NCT03537248
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Asepticys LLC

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE April 23, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Slit Lamp Findings [ Time Frame: 3 months ]
    Statistical non-inferiority with respect to the proportion of eyes with any slit-lamp findings greater than Grade 2 at any visit between the test and control solutions
  • Visual Acuity [ Time Frame: 3 months ]
    Statistical non-inferiority with respect to the proportion of subjects with greater than 2-line worsening in visual acuity in any eye at any visit between the test and control solutions
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03537248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Effectiveness Study of a New Multi-Purpose Contact Lens Care Solution
Official Title  ICMJE Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution
Brief Summary The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks).
Detailed Description Approximately 330 subjects (660 eyes) will be enrolled in this 3 month (12 week) controlled, parallel group, masked, randomized study at approximately 15 investigative sites in the United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57 Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both Test and Control solution will be used with a rub care regimen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Contact Lens Wear
Intervention  ICMJE
  • Device: ASP-57
    an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
    Other Name: Investigational Multi-Purpose Contact Lens Care Solution
  • Device: ReNu® Multiplus
    a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
Study Arms  ICMJE
  • Experimental: Asepticys investigational ASP-57 Multi-Purpose Solution
    ASP-57 Multi-Purpose contact lens care solution used as a rub care regimen (Test)
    Intervention: Device: ASP-57
  • Active Comparator: ReNu® Multiplus Contact Lens Solution
    ReNu® Multiplus Contact Lens Solution used as rub care regimen (Control)
    Intervention: Device: ReNu® Multiplus
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: February 7, 2019)
315
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
330
Actual Study Completion Date  ICMJE October 30, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects age ≥ 18 years on the date of informed consent.
  2. All subjects must provide signed written consent prior to participation in any study related procedures.
  3. Successful history of wear of the one of the following lens types (toric and multifocal lenses of the specified lens type are allowed) in both eyes during the past 3 months, and history of at least 5 consecutive days of successful daily wear in both eyes prior to Visit 1:

    • All Bausch & Lomb PureVision lens types
    • All Alcon Air Optix lens types
    • All CooperVision Biofinity lens types
    • All Vistakon Acuvue Oasys lens types
    • Any conventional hydrogel Group IV lens
  4. Vision correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
  5. Clear central corneas and free of any anterior segment disorders
  6. Habitual use of a Multi-Purpose Solution for cleaning, disinfecting, and storage of lenses.
  7. Lens correction in both eyes is required and the same brand of lens is worn in each eye.
  8. Agree to wear study lenses in both eyes on a daily wear basis, with lenses removed every night (not slept in) throughout the study period and no lens or pair of lenses worn for longer than 2 weeks.
  9. Able and willing to comply with all care regimen and follow-up study procedures.

Exclusion Criteria:

  1. Females of childbearing potential (not surgically sterilized or postmenopausal) if any one of the following conditions are met:

    • currently pregnant,
    • plan to become pregnant during the study,
    • are breast-feeding.
  2. Wear of gas permeable contact lenses within the last 30 days.
  3. Wear of polymethylmethacrylate lenses within the last 3 months.
  4. No topical ocular prescription medications may be administered during the study period. Ongoing use of non-preserved artificial tears up to 4 times daily (with no changes in frequency or brand) is allowed. Ongoing use of the rewetting drop the subject customarily uses (with no switch in brand or type) is also permitted during the study period.
  5. Current systemic disease affecting ocular health or use of topical or systemic medications that, in the Investigator's opinion, could affect ocular physiology or lens performance.
  6. Ocular astigmatism of 2.00 D or greater in either eye based on the contact lens prescription.
  7. Grade 2 or greater finding on any slit-lamp scale and/or corneal infiltrates of any grade during slit-lamp examination at Screening.
  8. Any finding during slit-lamp examination that, in the Investigator's opinion, interferes with contact lens wear.
  9. Scar or neovascularization within the central 4 millimeters (mm) of the cornea. Minor peripheral corneal scarring (that does not extend into the central zone) is permitted, if in the Investigator's judgment, it does not interfere with contact lens wear.
  10. Aphakia.
  11. Amblyopia.
  12. History of any corneal surgery.
  13. Allergy to any component of the study solutions.
  14. Participation in any clinical study within the 2 weeks prior to entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older 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 NCT03537248
Other Study ID Numbers  ICMJE ASP-57-101
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: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Asepticys LLC
Study Sponsor  ICMJE Asepticys LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Asepticys LLC
Verification Date June 2018

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