Clinical trial NCT03897751: A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses
Official title: A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Keywords: Contact Lens Cleaning Solution
Disinfectants, Contact Lens
Soft Contact Lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall Comfort
timeFrame: Month 3
measure: Eye Dryness
timeFrame: Month 3
measure: Degree Of Lens Deposits
timeFrame: Month 3
measure: Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings
timeFrame: Day 0 (post-dispensing) through Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Bausch Site 1
state: Alabama
city: San Diego
country: United States
facility: Bausch Site 2
state: California
city: San Francisco
country: United States
facility: Bausch Site 3
state: California
city: Denver
country: United States
facility: Bausch Site 4
state: Colorado
city: Sarasota
country: United States
facility: Bausch Site 5
state: Florida
city: Decatur
country: United States
facility: Bausch Site 6
state: Georgia
city: Bloomington
country: United States
facility: Bausch Site 7
state: Illinois
city: Leavenworth
country: United States
facility: Bausch Site 9
state: Kansas
city: Pittsburg
country: United States
facility: Bausch Site 8
state: Kansas
city: Portland
country: United States
facility: Bausch Site 10
state: Maine
city: East Lansing
country: United States
facility: Bausch Site 11
state: Michigan
city: Saint Louis
country: United States
facility: Bausch Site 12
state: Missouri
city: Jamestown
country: United States
facility: Bausch Site 13
state: New York
city: Vestal
country: United States
facility: Bausch Site 14
state: New York
city: State College
country: United States
facility: Bausch Site 15
state: Pennsylvania
city: Brentwood
country: United States
facility: Bausch Site 17
state: Tennessee
city: Nashville
country: United States
facility: Bausch Site 16
state: Tennessee
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Johnson Varughese
role: STUDY_DIRECTOR
References: