An interventional study of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. and Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. in Comfort, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-12.
Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Supportive care
The objective of the study is to evaluate the product performance of Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration
Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
Daily care for contact lenses.
Daily care for contact lenses
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
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
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
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.
| Milestone | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Clear Bottle ReNu MultiPlus Multi-Purpose Solution |
|---|---|---|
| Started | 157 | 151 |
| Completed | 153 | 147 |
| Not completed | 4 | 4 |
| Withdrew: Study related symptoms and complaints | 2 | 1 |
| Withdrew: Inability to maintain wearing schedule | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| Units on a Scale | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Clear Bottle ReNu MultiPlus Multi-Purpose Solution |
|---|---|---|
| Comfort | 90.2 ± 12.7 | 92.7 ± 9.3 |
| End of Day Comfort | 84.5 ± 16.9 | 87.2 ± 14.5 |
| Burning/Stinging on Insertion | 90.3 ± 15.8 | 93.2 ± 13.9 |
| Irritation | 90.2 ± 14.1 | 92.9 ± 10.6 |
| Itching | 93.0 ± 10.7 | 94.9 ± 9.3 |
| Dryness | 88.8 ± 14.4 | 90.5 ± 11.8 |
| Redness | 93.4 ± 11.8 | 94.0 ± 11.2 |
| Vision | 93.5 ± 12.4 | 95.7 ± 7.8 |
| Lens Cleanliness | 92.7 ± 12.4 | 92.7 ± 12.4 |
| Lens Handling | 96.7 ± 7.3 | 95.3 ± 10.3 |
Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.
| Eyes | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Clear Bottle ReNu MultiPlus Multi-Purpose Solution |
|---|---|---|
| Slit Lamp Finding > Grade 2 | 1 | 0 |
| Slit Lamp Findings </= Grade 2 | 311 | 304 |
Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.
| Eyes | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Clear Bottle ReNu MultiPlus Multi-Purpose Solution |
|---|---|---|
| Absent | 292 | 281 |
| Present | 18 | 19 |
Collected over One month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | — | 0/157 (0%) | 0/157 (0%) |
| Clear Bottle ReNu MultiPlus Multi-Purpose Solution | — | 0/151 (0%) | 0/151 (0%) |
| Age, Customized(Participants) | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Total |
|---|---|---|---|
| >=18 and <=65 years | 157 | 151 | 308 |
| Sex: Female, Male(Participants) | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Total |
|---|---|---|---|
| Female | 119 | 111 | 230 |
| Male | 38 | 40 | 78 |
| Race/Ethnicity, Customized(Participants) | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 8 | 7 | 15 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Black or African American | 3 | 6 | 9 |
| White | 144 | 136 | 280 |
| Region of Enrollment(participants) | Marketed Bottle ReNu MultiPlus Multi-Purpose Solution | Clear Bottle ReNu MultiPlus Multi-Purpose Solution | Total |
|---|---|---|---|
| United States | 157 | 151 | 308 |
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Bausch & Lomb Incorporated