Refractive Ametropia
Conditions
Brief summary
Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.
Interventions
DEVICEBL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
DEVICErenu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
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
1. Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed 2. Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations 3. Is a habitual wearer (at least 3 months) 4. Has typically cleaned and disinfected their pre-study contact lenses daily 5. Must have spectacle correctable distance visual acuity through spherocylindrical refraction to 40 letters (0.14 logarithm of the minimal angle of resolution (logMAR) or better in each eye, at 2 meters distance with high contrast chart 6. Has clear central corneas and is free of any anterior segment disorders 7. Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses 8. Requires lens correction in both eyes 9. Wears the same manufacturer and brand of lens in both eyes 10. Agrees to wear study lenses on a daily wear basis for approximately three months 11. Is willing and able to comply with all treatment and follow-up/study procedures.
Exclusion criteria
1. Is currently using a hydrogen-peroxide cleaning and disinfecting solution 2. Participated in any drug or device clinical investigation within 30 days prior to entry into this study 3. Is a female of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following conditions: * they are currently pregnant * they plan to become pregnant during the study * they are breastfeeding 4. Has worn gas permeable (GP) lenses within the last 30 days 5. Has worn polymethylmethacrylate (PMMA) lenses within the last three months 6. Has typically worn their pre-study contact lenses on an extended wear basis, sleeping in their lenses one night or more per week, during the last year 7. 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 8. Subjects with an active ocular disease, or who are using any ocular medication. 9. Is using any medications that will, in the Investigator's opinion, affect ocular physiology or lens performance 10. Currently wears monovision, multifocal, or toric contact lenses 11. Has ocular astigmatism of 1.00D or greater in either eye 12. Has anisometropia (spherical equivalent) of greater than 2.00D 13. Has any grade 2 or greater finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation) 14. Has corneal infiltrates, of ANY GRADE 15. Has any Present ungraded finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation) that, in the Investigator's judgment, interferes with contact lens wear. 16. Has typically worn their pr-study control lenses on an extended wear bases, sleeping on their lenses one night or more per week, during the last year. 17. Is aphakic 18. Is amblyopic 19. Has had any corneal surgery (e.g., refractive surgery) 20. Is allergic to any component in the study care products. 21. 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 22. Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties 23. Is an employee of a manufacturer of contact lenses or contact lens care products (e.g., Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, Johnson & Johnson, etc.) or currently resides with a person employed by any of these manufacturers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort Averaged Over All Follow-up Visits | Assessed at all follow-up visits through 3 months. | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response |
| Vision Averaged Over All Follow-up Visits | Assessed at all follow-up visits through 3 months. | Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response |
| The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits. | Assessed at all follow-up visits through 3 months. | The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface. 1. \- Very slight, only visible after tear film drying. 2. \- Slight, visible deposits easily removable. 3. \- Moderate, deposits adherent and not removable. 4. \- Severe, non-removable deposits and comfort affected. |
| The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits. | Assessed at 3 months | Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BL-3100-NBR03 BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses | 143 |
| Renu® Advanced Formula renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses | 152 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Anisometropia | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Persistent study-related symptoms /complaints | 1 | 1 |
| Overall Study | Pregnancy | 0 | 2 |
Baseline characteristics
| Characteristic | BL-3100-NBR03 | Total | Renu® Advanced Formula |
|---|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 10.26 | 36.5 years STANDARD_DEVIATION 10.08 | 37.5 years STANDARD_DEVIATION 9.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 15 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants | 280 Participants | 146 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 33 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 29 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 109 Participants | 221 Participants | 112 Participants |
| Region of Enrollment United States | 143 participants | 295 participants | 152 participants |
| Sex: Female, Male Female | 100 Participants | 209 Participants | 109 Participants |
| Sex: Female, Male Male | 43 Participants | 86 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 143 | 0 / 151 |
| other Total, other adverse events | 0 / 143 | 0 / 151 |
| serious Total, serious adverse events | 0 / 143 | 1 / 151 |
Outcome results
Primary
Overall Comfort Averaged Over All Follow-up Visits
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
Time frame: Assessed at all follow-up visits through 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BL-3100-NBR03 | Overall Comfort Averaged Over All Follow-up Visits | 91.7 score on a scale | Standard Deviation 9.99 |
| Renu® Advanced Formula | Overall Comfort Averaged Over All Follow-up Visits | 90.7 score on a scale | Standard Deviation 10.83 |
Primary
The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits.
The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface. 1. \- Very slight, only visible after tear film drying. 2. \- Slight, visible deposits easily removable. 3. \- Moderate, deposits adherent and not removable. 4. \- Severe, non-removable deposits and comfort affected.
Time frame: Assessed at all follow-up visits through 3 months.
Population: All randomized subjects with at least one non-missing values for front surface deposit grading. Two subjects (4 eyes) in the BL-3100-NBR03 arm and 1 subject (2 eyes) in the renu Advanced Formula arm with no front surface grading measurements reported were excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BL-3100-NBR03 | The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits. | The Percentage of Eyes with Front Surface Deposits Grade of <= 2 | 99.3 percentage of eyes |
| BL-3100-NBR03 | The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits. | The Percentage of Eyes with Front Surface Deposits Grade of >2 | 0.7 percentage of eyes |
| Renu® Advanced Formula | The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits. | The Percentage of Eyes with Front Surface Deposits Grade of <= 2 | 97.7 percentage of eyes |
| Renu® Advanced Formula | The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits. | The Percentage of Eyes with Front Surface Deposits Grade of >2 | 2.3 percentage of eyes |
Primary
The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.
Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4.
Time frame: Assessed at 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BL-3100-NBR03 | The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits. | Present | 0 percentage of eyes |
| BL-3100-NBR03 | The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits. | Absent | 100 percentage of eyes |
| Renu® Advanced Formula | The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits. | Present | 0.7 percentage of eyes |
| Renu® Advanced Formula | The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits. | Absent | 99.3 percentage of eyes |
Primary
Vision Averaged Over All Follow-up Visits
Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
Time frame: Assessed at all follow-up visits through 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BL-3100-NBR03 | Vision Averaged Over All Follow-up Visits | 95.5 score on a scale | Standard Deviation 6.69 |
| Renu® Advanced Formula | Vision Averaged Over All Follow-up Visits | 94.3 score on a scale | Standard Deviation 7.75 |