Contact Lens WearNCT03897751
A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses
A study testing ABT12 Multi-Purpose Solution, COMPLETE Multi-Purpose Solution and Sensitive Eyes® Rewetting Drops in people with Contact Lens Wear, run by Bausch & Lomb Incorporated at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Wear
- What is being tested?
- ABT12 Multi-Purpose Solution, COMPLETE Multi-Purpose Solution and Sensitive Eyes® Rewetting Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 17 sitesUnited States
- Study dates
- 8 Mar 2019to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Bausch Site 1
Birmingham, Alabama, 35216
Bausch Site 7
Bloomington, Illinois, 61701
Bausch Site 17
Brentwood, Tennessee, 37027
Bausch Site 6
Decatur, Georgia, 30035
Bausch Site 4
Denver, Colorado, 80246
Bausch Site 11
East Lansing, Michigan, 48823
Bausch Site 13
Jamestown, New York, 14701
Bausch Site 9
Leavenworth, Kansas, 66048
Bausch Site 16
Nashville, Tennessee, 37205
Bausch Site 8
Pittsburg, Kansas, 66762
Bausch Site 10
Portland, Maine, 04101
Bausch Site 2
San Diego, California, 92123
Bausch Site 3
San Francisco, California, 94112
Bausch Site 5
Sarasota, Florida, 34232
Bausch Site 12
St Louis, Missouri, 63144
Bausch Site 15
State College, Pennsylvania, 16801
Bausch Site 14
Vestal, New York, 13850
About this study
Official title: 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.
Read the 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
- Conditions
- Contact Lens Wear
- Being tested
- ABT12 Multi-Purpose Solution, COMPLETE Multi-Purpose Solution, Sensitive Eyes® Rewetting Drops
- Keywords
- Contact Lens Cleaning Solution, Disinfectants, Contact Lens, Soft Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT12 Multi-Purpose SolutionDevice
Contact lens cleaning and disinfecting solution
COMPLETE Multi-Purpose SolutionDevice
Also called COMPLETE® Multi-Purpose Solution Easy Rub® Formula
Contact lens cleaning and disinfecting solution
Sensitive Eyes® Rewetting DropsDevice
For use as needed during the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: COMPLETE Multi-Purpose Solution; Device: Sensitive Eyes® Rewetting Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Comfort
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.
Measured: 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.
Measured: Month 3
Degree Of Lens Deposits
Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy.
Measured: 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)
Measured: Day 0 (post-dispensing) through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start8 Mar 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contact Lens WearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson Varughese, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897751
- Sponsor's protocol ID
- 932
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2019
- Last updated
- 3 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40216672
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
- ClinicalTrials.gov ID
- NCT03897751
- Acronym / sponsor ID
- 932
- Conditions
- Contact Lens Wear
- Keywords
- Contact Lens Cleaning Solution, Disinfectants, Contact Lens, Soft Contact Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT12 Multi-Purpose Solution | Experimental | Device: ABT12 Multi-Purpose Solution, Device: Sensitive Eyes® Rewetting DropsParticipants 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. |
| COMPLETE Multi-Purpose Solution | Active comparator | Device: COMPLETE Multi-Purpose Solution, Device: Sensitive Eyes® Rewetting DropsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT12 Multi-Purpose SolutionContact lens cleaning and disinfecting solution | Device | ABT12 Multi-Purpose Solution |
| COMPLETE Multi-Purpose SolutionAlso: COMPLETE® Multi-Purpose Solution Easy Rub® FormulaContact lens cleaning and disinfecting solution | Device | COMPLETE Multi-Purpose Solution |
| Sensitive Eyes® Rewetting DropsFor use as needed during the study. | Device | ABT12 Multi-Purpose Solution, COMPLETE Multi-Purpose Solution |
Primary outcome
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.
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.
Degree Of Lens Deposits
Time frame: Month 3
Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy.
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40216672Schaeffer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson Varughese study director
Bausch & Lomb Incorporated
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABT12 Multi-Purpose Solution, COMPLETE Multi-Purpose Solution and Sensitive Eyes® Rewetting Drops in people with Contact Lens Wear, run by Bausch & Lomb Incorporated at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Comfort (time frame: Month 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03897751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.