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

NCT03537248 | Completed FDA Device

• 1 other identifier: ASP-57-101
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 14

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).

Conditions

Contact Lens Wear

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Asepticys investigational ASP-57 Multi-Purpose Solution

EXPERIMENTAL

ASP-57 Multi-Purpose contact lens care solution used as a rub care regimen (Test)

Device: ASP-57

ReNu® Multiplus Contact Lens Solution

ACTIVE COMPARATOR

ReNu® Multiplus Contact Lens Solution used as rub care regimen (Control)

Device: ReNu® Multiplus

Interventions

ASP-57 DEVICE

an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses

Also known as: Investigational Multi-Purpose Contact Lens Care Solution

Asepticys investigational ASP-57 Multi-Purpose Solution

ReNu® Multiplus DEVICE

a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses

ReNu® Multiplus Contact Lens Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Asepticys LLC: lead

Study Sites (14)

Lakeside Vision Center

Irvine, California, 92604, United States

Location

Complete Family Vision Care

San Diego, California, 92123, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Eye Care Associates

Bloomington, Illinois, 61701, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Heart of America Eye Care

Shawnee Mission, Kansas, 66204, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Insight Eyecare

Warrensburg, Missouri, 64093, United States

Location

Drs Quinn, Foster & Associates

Athens, Ohio, 45701, United States

Location

West Bay Eye

Warwick, Rhode Island, 02888, United States

Location

Optometry Group

Memphis, Tennessee, 38111, United States

Location

Optique Eyecare

Nashville, Tennessee, 37203, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: April 23, 2018
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: February 11, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)