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

March 2, 2023 updated by: Bausch & Lomb Incorporated

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Comfort
Time Frame: Month 3
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
Time Frame: Month 3
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
Time Frame: Month 3
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
Time Frame: Day 0 (post-dispensing) through Month 3

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch & Lomb Incorporated

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Johnson Varughese, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2019

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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