Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution
ASP-57
+ ReNu® Multiplus
Treatment Study
Summary
Study start date: April 23, 2018
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.315 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
Complete Family Vision Care
San Diego, United StatesSabal Eye Care
Longwood, United StatesMaitland Vision Center
Maitland, United States