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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

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).

Condition or disease Intervention/treatment Phase
Contact Lens Wear Device: ASP-57 Device: ReNu® Multiplus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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 Name: 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




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03537248


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

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Responsible Party: Asepticys LLC
ClinicalTrials.gov Identifier: NCT03537248     History of Changes
Other Study ID Numbers: ASP-57-101
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Contact Lens Solutions
Pharmaceutical Solutions
Disinfectants
Anti-Infective Agents