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

Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution

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).

Study Overview

• Status: Completed
• Conditions: Contact Lens Wear
• Intervention / Treatment: Device: ASP-57; Device: ReNu® Multiplus

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: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92604
      • Lakeside Vision Center
    • San Diego, California, United States, 92123
      • Complete Family Vision Care
  • Florida
    • Longwood, Florida, United States, 32779
      • Sabal Eye Care
    • Maitland, Florida, United States, 32751
      • Maitland Vision Center
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Eye Care Associates
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
    • Shawnee Mission, Kansas, United States, 66204
      • Heart of America Eye Care
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Missouri
    • Warrensburg, Missouri, United States, 64093
      • InSight Eyecare
  • Ohio
    • Athens, Ohio, United States, 45701
      • Drs Quinn, Foster & Associates
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group
    • Nashville, Tennessee, United States, 37203
      • Optique Eyecare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asepticys investigational ASP-57 Multi-Purpose Solution; ASP-57 Multi-Purpose contact lens care solution used as a rub care regimen (Test)	Device: ASP-57; an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses; Other Names: Investigational Multi-Purpose Contact Lens Care Solution
Active Comparator: ReNu® Multiplus Contact Lens Solution; ReNu® Multiplus Contact Lens Solution used as rub care regimen (Control)	Device: ReNu® Multiplus; a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Findings	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	3 months
Visual Acuity	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	3 months

Collaborators and Investigators

• Sponsor: Asepticys LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: ASP-57-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: No