Contact Lens Wear
Conditions
Keywords
Contact Lens Cleaning Solution, Disinfectants, Contact Lens, Soft Contact Lens
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
Interventions
DEVICEABT12 Multi-Purpose Solution
Contact lens cleaning and disinfecting solution
DEVICECOMPLETE Multi-Purpose Solution
Contact lens cleaning and disinfecting solution
DEVICESensitive Eyes® Rewetting Drops
For use as needed during the study.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | 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 | 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 | 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 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
ABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution
Sensitive Eyes® Rewetting Drops: For use as needed during the study. | 127 |
| 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.
COMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution
Sensitive Eyes® Rewetting Drops: For use as needed during the study. | 125 |
| Total | 252 |
Baseline characteristics
| Characteristic | COMPLETE Multi-Purpose Solution | Total | ABT12 Multi-Purpose Solution |
|---|---|---|---|
| Age, Continuous | 34.1 years STANDARD_DEVIATION 9.79 | 34.3 years STANDARD_DEVIATION 9.74 | 34.4 years STANDARD_DEVIATION 9.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 21 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 24 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 103 Participants | 204 Participants | 101 Participants |
| Sex: Female, Male Female | 91 Participants | 179 Participants | 88 Participants |
| Sex: Female, Male Male | 34 Participants | 73 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 125 |
| other Total, other adverse events | 0 / 127 | 0 / 125 |
| serious Total, serious adverse events | 0 / 127 | 0 / 125 |
Outcome results
Primary
Degree Of Lens Deposits
Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy.
Time frame: Month 3
Population: Randomized participants who attended the 3-month visit and did not have major protocol deviations
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ABT12 Multi-Purpose Solution | Degree Of Lens Deposits | None or Light | 231 Eyes |
| ABT12 Multi-Purpose Solution | Degree Of Lens Deposits | Medium or Heavy | 3 Eyes |
| COMPLETE Multi-Purpose Solution | Degree Of Lens Deposits | None or Light | 222 Eyes |
| COMPLETE Multi-Purpose Solution | Degree Of Lens Deposits | Medium or Heavy | 4 Eyes |
Primary
Eye Dryness
Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.
Time frame: Month 3
Population: Randomized participants who attended the 3-month visit and did not have major protocol deviations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABT12 Multi-Purpose Solution | Eye Dryness | 84.2 score on a scale | Standard Deviation 15.15 |
| COMPLETE Multi-Purpose Solution | Eye Dryness | 83.1 score on a scale | Standard Deviation 14.99 |
Primary
Overall Comfort
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.
Time frame: Month 3
Population: Randomized participants who attended the 3-month visit and did not have major protocol deviations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABT12 Multi-Purpose Solution | Overall Comfort | 88.9 score on a scale | Standard Deviation 11.49 |
| COMPLETE Multi-Purpose Solution | Overall Comfort | 87.5 score on a scale | Standard Deviation 12.24 |
Primary
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)
Time frame: Day 0 (post-dispensing) through Month 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABT12 Multi-Purpose Solution | Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings | 0 Participants |
| COMPLETE Multi-Purpose Solution | Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings | 1 Participants |