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

NCT03897751 | Completed Results FDA Device

• 1 other identifier: 932
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Contact Lens Wear

Keywords

Contact Lens Cleaning Solution; Disinfectants, Contact Lens; Soft Contact Lens

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

ABT12 Multi-Purpose Solution

EXPERIMENTAL

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; Device: Sensitive Eyes® Rewetting Drops

COMPLETE Multi-Purpose Solution

ACTIVE COMPARATOR

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: COMPLETE Multi-Purpose Solution; Device: Sensitive Eyes® Rewetting Drops

Interventions

ABT12 Multi-Purpose Solution DEVICE

Contact lens cleaning and disinfecting solution

ABT12 Multi-Purpose Solution

COMPLETE Multi-Purpose Solution DEVICE

Contact lens cleaning and disinfecting solution

Also known as: COMPLETE® Multi-Purpose Solution Easy Rub® Formula

COMPLETE Multi-Purpose Solution

Sensitive Eyes® Rewetting Drops DEVICE

For use as needed during the study.

ABT12 Multi-Purpose Solution; COMPLETE Multi-Purpose Solution

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (17)

Bausch Site 1

Birmingham, Alabama, 35216, United States

Location

Bausch Site 2

San Diego, California, 92123, United States

Location

Bausch Site 3

San Francisco, California, 94112, United States

Location

Bausch Site 4

Denver, Colorado, 80246, United States

Location

Bausch Site 5

Sarasota, Florida, 34232, United States

Location

Bausch Site 6

Decatur, Georgia, 30035, United States

Location

Bausch Site 7

Bloomington, Illinois, 61701, United States

Location

Bausch Site 9

Leavenworth, Kansas, 66048, United States

Location

Bausch Site 8

Pittsburg, Kansas, 66762, United States

Location

Bausch Site 10

Portland, Maine, 04101, United States

Location

Bausch Site 11

East Lansing, Michigan, 48823, United States

Location

Bausch Site 12

St Louis, Missouri, 63144, United States

Location

Bausch Site 13

Jamestown, New York, 14701, United States

Location

Bausch Site 14

Vestal, New York, 13850, United States

Location

Bausch Site 15

State College, Pennsylvania, 16801, United States

Location

Bausch Site 17

Brentwood, Tennessee, 37027, United States

Location

Bausch Site 16

Nashville, Tennessee, 37205, United States

Location

Related Publications (1)

• Schaeffer M, Shahidi A, Mosehauer G, Rah M, Reindel W. Clinical Evaluation of Biotrue Hydration Plus Multipurpose Solution in Daily Use with Planned Replacement Soft Contact Lenses. Ophthalmol Ther. 2025 Jun;14(6):1249-1260. doi: 10.1007/s40123-025-01123-0. Epub 2025 Apr 11.

  PMID: 40216672 DERIVED

Results Point of Contact

• Title: Johnson Varughese
• Organization: Bausch & Lomb

Johnson.Varughese@bauschhealth.com

9089271162

Study Officials

• Johnson Varughese

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 1, 2019
• Study Start: March 8, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 3, 2023
• Results First Posted: November 30, 2022

Record last verified: 2023-03

Locations

US (17)