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

Completed · Not applicable

Conditions studied: Contact Lens Wear

In brief

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).

Key facts

Study ID

NCT03537248

Run by

Asepticys LLC

People needed

315

Starts

2018-04-23

Expected to finish

2018-10-30

Last updated by the study team

2019-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects age ≥ 18 years on the date of informed consent.
• All subjects must provide signed written consent prior to participation in any study related procedures.
• 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
• Vision correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Clear central corneas and free of any anterior segment disorders
• Habitual use of a Multi-Purpose Solution for cleaning, disinfecting, and storage of lenses.
• Lens correction in both eyes is required and the same brand of lens is worn in each eye.
• 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.
• Able and willing to comply with all care regimen and follow-up study procedures.

You may not qualify if…

• 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.
• Wear of gas permeable contact lenses within the last 30 days.
• Wear of polymethylmethacrylate lenses within the last 3 months.
• 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.
• 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.
• Ocular astigmatism of 2.00 D or greater in either eye based on the contact lens prescription.
• Grade 2 or greater finding on any slit-lamp scale and/or corneal infiltrates of any grade during slit-lamp examination at Screening.
• Any finding during slit-lamp examination that, in the Investigator's opinion, interferes with contact lens wear.
• 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.
• Aphakia.
• Amblyopia.
• History of any corneal surgery.
• Allergy to any component of the study solutions.
• Participation in any clinical study within the 2 weeks prior to entry into this study.

Where it is running

• Lakeside Vision Center — Irvine, California, United States
• Complete Family Vision Care — San Diego, California, United States
• Sabal Eye Care — Longwood, Florida, United States
• Maitland Vision Center — Maitland, Florida, United States
• Vision Health Institute — Orlando, Florida, United States
• Eye Care Associates — Bloomington, Illinois, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Heart of America Eye Care — Shawnee Mission, Kansas, United States
• Seidenberg Protzko Eye Associates — Havre de Grace, Maryland, United States
• Insight Eyecare — Warrensburg, Missouri, United States
• Drs Quinn, Foster & Associates — Athens, Ohio, United States
• West Bay Eye — Warwick, Rhode Island, United States
• Optometry Group — Memphis, Tennessee, United States
• Optique Eyecare — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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