A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses

A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution

This study is to evaluate the safety and effectiveness of ABT12 Multi-Purpose solution (Test) compared to COMPLETE® Multi-Purpose Solution Easy Rub® Formula ("COMPLETE Multi-Purpose Solution") when used by participants who are habitual contact lens wearers.

Study Overview

• Status: Completed
• Conditions: Contact Lens Wear
• Intervention / Treatment: Device: ABT12 Multi-Purpose Solution; Device: Sensitive Eyes® Rewetting Drops; Device: COMPLETE Multi-Purpose Solution

Detailed Description

Eligible participants will be enrolled from 1 of 5 lens groups based on their habitual contact lenses. Participants will be randomized on a 1:1 basis within each group per site to receive either ABT12 Multi-Purpose solution or COMPLETE Multi-Purpose Solution. The 5 lens groups will be comprised of habitual wearers of soft lenses based on the following lens material:

• Etaficon A, Acuvue2, Vistakon
• Balafilcon A, PureVision2, Bausch + Lomb
• Samfilcon A, Ultra, Bausch + Lomb
• Lotrafilcon B, Optix Aqua, Alcon
• Senofilcon C, Vita, Vistakon

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Bausch Site 1
  • California
    • San Diego, California, United States, 92123
      • Bausch Site 2
    • San Francisco, California, United States, 94112
      • Bausch Site 3
  • Colorado
    • Denver, Colorado, United States, 80246
      • Bausch Site 4
  • Florida
    • Sarasota, Florida, United States, 34232
      • Bausch Site 5
  • Georgia
    • Decatur, Georgia, United States, 30035
      • Bausch Site 6
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Bausch Site 7
  • Kansas
    • Leavenworth, Kansas, United States, 66048
      • Bausch Site 9
    • Pittsburg, Kansas, United States, 66762
      • Bausch Site 8
  • Maine
    • Portland, Maine, United States, 04101
      • Bausch Site 10
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • Bausch Site 11
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • Bausch Site 12
  • New York
    • Jamestown, New York, United States, 14701
      • Bausch Site 13
    • Vestal, New York, United States, 13850
      • Bausch Site 14
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Bausch Site 15
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Bausch Site 17
    • Nashville, Tennessee, United States, 37205
      • Bausch Site 16

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:

• Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate local privacy regulations
• Is a habitual wearer (at least 3 months) of one of the following lens types: 1) Etaficon A, Acuvue2, Vistakon; 2) Balafilcon A, PureVision2, Bausch + Lomb; 3) Samfilcon A, Ultra, Bausch + Lomb; 4) Lotrafilcon B, Optix Aqua, Alcon; 5) Senofilcon C, Vita, Vistakon
• Vision is correctable through spherocylindrical refraction to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (distance, high contrast) in each eye with soft spherical contact lenses
• Has clear central corneas and is free of any anterior segment disorders
• Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses
• Requires lens correction in both eyes
• Wears the same manufacturer and brand of lens in both eyes
• Agrees to wear study lenses on a daily wear basis for approximately 3 months
• Is willing and able to comply with all treatment and follow-up/study procedures

Exclusion Criteria:

• Participants who currently use a hydrogen-peroxide cleaning and disinfecting solution
• Participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation
• Females of childbearing potential (those who are not surgically sterilized or postmenopausal), if they are currently pregnant, plan to become pregnant during the study, or are breastfeeding
• Has worn gas permeable (GP) lenses within the last 30 days.
• Has worn polymethylmethacrylate (PMMA) lenses within the last 3 months
• Has any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study
• Has any ocular disease or is using any ocular medication
• Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance
• Currently wears monovision, multifocal, or toric contact lenses
• Has ocular astigmatism of 1.00 diopter (D) or greater in either eye
• Vision is not correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses
• Has anisometropia (spherical equivalent) of greater than 2.00D
• Has any Grade 2 or greater finding during the slit lamp examination
• Has corneal infiltrates, of any grade
• Participants with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear
• Has any scar or neovascularization within the central 6 millimeters (mm) of the cornea. Note that participants with minor peripheral corneal scarring (that does not extend into the central area), that, in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study
• Is aphakic
• Is amblyopic
• Has had any corneal surgery (for example, refractive surgery)
• Is allergic to any component in the study care products
• Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee's household
• Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties
• Is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, or Johnson & Johnson) or currently resides with a person employed by any of these manufacturers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT12 Multi-Purpose Solution; Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.	Device: ABT12 Multi-Purpose Solution; Contact lens cleaning and disinfecting solution; Device: Sensitive Eyes® Rewetting Drops; For use as needed during the study.
Active Comparator: COMPLETE Multi-Purpose Solution; Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.	Device: Sensitive Eyes® Rewetting Drops; For use as needed during the study.; Device: COMPLETE Multi-Purpose Solution; Contact lens cleaning and disinfecting solution; Other Names: COMPLETE® Multi-Purpose Solution Easy Rub® Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort	Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.	Month 3
Eye Dryness	Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.	Month 3
Degree Of Lens Deposits	Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy.	Month 3
Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings	Graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Greater than Grade 2 findings (Absent, Present) will be summarized at the eye level by treatment. Grades are 0(none), 1 (Trace), 2 (Mild), 3 (moderate), 4 (severe)	Day 0 (post-dispensing) through Month 3

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Johnson Varughese, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Soft Contact Lens; Contact Lens Cleaning Solution; Disinfectants, Contact Lens
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 932 (Duke)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes