Comfort
Conditions
Brief summary
The objective of the study is to evaluate the product performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration
Interventions
DEVICEBausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
Daily care for contact lenses.
DEVICEBausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
Daily care for contact lenses
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is a habitual wearer of planned replacement soft contact lenses * VA correctable to 0.3 LogMar or better (driving vision) * Clear central cornea * Subject uses a lens care system on a regular basis
Exclusion criteria
* Systemic disease affecting ocular health * Using systemic or topical medications * Wear monovision, multifocal or toric contact lenses * Any grade 2 or greater slit lamp findings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | Over-all follow-up visits from baseline to 1 month | Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating. |
| Slit Lamp Findings | Over-all follow-up visits from baseline to1 month | Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe. |
| Lens Deposits | Over-all study visits, baseline to 1-month | Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy. |
Countries
United States
Participant flow
Recruitment details
This study was conducted in 23 investigative sites in the United States. First participant was enrolled 3/19/2008, last participant exited the study 5/19/08.
Pre-assignment details
312 Participants were enrolled, 2 participants were ineligible at baseline but were dispensed lens care solution and completed the study. 2 participants were not dispensed lens care solution. 308 eligible subjects started the study, 8 were discontinued during the study. 300 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care. | 157 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care. | 151 |
| Total | 308 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inability to maintain wearing schedule | 1 | 2 |
| Overall Study | Study related symptoms and complaints | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution |
|---|---|---|---|
| Age, Customized >=18 and <=65 years | 308 Participants | 151 Participants | 157 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 15 Participants | 7 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 280 Participants | 136 Participants | 144 Participants |
| Region of Enrollment United States | 308 participants | 151 participants | 157 participants |
| Sex: Female, Male Female | 230 Participants | 111 Participants | 119 Participants |
| Sex: Female, Male Male | 78 Participants | 40 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 157 | 0 / 151 |
| serious Total, serious adverse events | 0 / 157 | 0 / 151 |
Outcome results
Primary
Comfort
Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.
Time frame: Over-all follow-up visits from baseline to 1 month
Population: Symptoms/Complaints Over-All Scheduled Follow-Up Visits (All Eligible, Dispensed Eyes with non-missing scores)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Comfort | 90.2 Units on a Scale | Standard Deviation 12.7 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | End of Day Comfort | 84.5 Units on a Scale | Standard Deviation 16.9 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Burning/Stinging on Insertion | 90.3 Units on a Scale | Standard Deviation 15.8 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Irritation | 90.2 Units on a Scale | Standard Deviation 14.1 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Itching | 93.0 Units on a Scale | Standard Deviation 10.7 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Dryness | 88.8 Units on a Scale | Standard Deviation 14.4 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Redness | 93.4 Units on a Scale | Standard Deviation 11.8 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Vision | 93.5 Units on a Scale | Standard Deviation 12.4 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Lens Cleanliness | 92.7 Units on a Scale | Standard Deviation 12.4 |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Lens Handling | 96.7 Units on a Scale | Standard Deviation 7.3 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Vision | 95.7 Units on a Scale | Standard Deviation 7.8 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Comfort | 92.7 Units on a Scale | Standard Deviation 9.3 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Dryness | 90.5 Units on a Scale | Standard Deviation 11.8 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | End of Day Comfort | 87.2 Units on a Scale | Standard Deviation 14.5 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Lens Handling | 95.3 Units on a Scale | Standard Deviation 10.3 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Burning/Stinging on Insertion | 93.2 Units on a Scale | Standard Deviation 13.9 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Redness | 94.0 Units on a Scale | Standard Deviation 11.2 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Irritation | 92.9 Units on a Scale | Standard Deviation 10.6 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Lens Cleanliness | 92.7 Units on a Scale | Standard Deviation 12.4 |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Comfort | Itching | 94.9 Units on a Scale | Standard Deviation 9.3 |
Primary
Lens Deposits
Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.
Time frame: Over-all study visits, baseline to 1-month
Population: Lens deposits over all scheduled follow-up visits (all eligible, dispensed eyes with non-missing data)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Lens Deposits | Absent | 292 Eyes |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Lens Deposits | Present | 18 Eyes |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Lens Deposits | Absent | 281 Eyes |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Lens Deposits | Present | 19 Eyes |
Primary
Slit Lamp Findings
Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.
Time frame: Over-all follow-up visits from baseline to1 month
Population: Graded Slit Lamp Findings over All Follow-Up Visits (Any finding, All Dispensed Eyes, 151 + 2 possible).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Slit Lamp Findings | Slit Lamp Finding > Grade 2 | 1 Eyes |
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Slit Lamp Findings | Slit Lamp Findings </= Grade 2 | 311 Eyes |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Slit Lamp Findings | Slit Lamp Finding > Grade 2 | 0 Eyes |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Slit Lamp Findings | Slit Lamp Findings </= Grade 2 | 304 Eyes |