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Trial Outcomes & Findings for Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration (NCT NCT00659815)

NCT ID: NCT00659815

Last Updated: 2011-12-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

312 participants

Primary outcome timeframe

Over-all follow-up visits from baseline to 1 month

Results posted on

2011-12-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
157
151
Overall Study
COMPLETED
153
147
Overall Study
NOT COMPLETED
4
4

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Study related symptoms and complaints
2
1
Overall Study
Inability to maintain wearing schedule
1
2
Overall Study
Withdrawal by Subject
1
1

Baseline Characteristics

Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Marketed Bottle ReNu MultiPlus Multi-Purpose Solution
n=157 Participants
Currently Marketed high-density polyethylene (HDPE) Bottle with B\&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
Clear Bottle ReNu MultiPlus Multi-Purpose Solution
n=151 Participants
Clear polyethylene terephthalate (PET) Bottle with B\&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
Total
n=308 Participants
Total of all reporting groups
Age, Customized
>=18 and <=65 years
157 Participants
n=5 Participants
151 Participants
n=7 Participants
308 Participants
n=5 Participants
Sex: Female, Male
Female
119 Participants
n=5 Participants
111 Participants
n=7 Participants
230 Participants
n=5 Participants
Sex: Female, Male
Male
38 Participants
n=5 Participants
40 Participants
n=7 Participants
78 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
3 Participants
n=5 Participants
6 Participants
n=7 Participants
9 Participants
n=5 Participants
Race/Ethnicity, Customized
White
144 Participants
n=5 Participants
136 Participants
n=7 Participants
280 Participants
n=5 Participants
Region of Enrollment
United States
157 participants
n=5 Participants
151 participants
n=7 Participants
308 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure
Marketed Bottle ReNu MultiPlus Multi-Purpose Solution
n=312 eyes
Currently Marketed high-density polyethylene (HDPE) Bottle with B\&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
Clear Bottle ReNu MultiPlus Multi-Purpose Solution
n=300 eyes
Clear polyethylene terephthalate (PET) Bottle with B\&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
Comfort
Redness
93.4 Units on a Scale
Standard Deviation 11.8
94.0 Units on a Scale
Standard Deviation 11.2
Comfort
Vision
93.5 Units on a Scale
Standard Deviation 12.4
95.7 Units on a Scale
Standard Deviation 7.8
Comfort
Lens Cleanliness
92.7 Units on a Scale
Standard Deviation 12.4
92.7 Units on a Scale
Standard Deviation 12.4
Comfort
Lens Handling
96.7 Units on a Scale
Standard Deviation 7.3
95.3 Units on a Scale
Standard Deviation 10.3
Comfort
Burning/Stinging on Insertion
90.3 Units on a Scale
Standard Deviation 15.8
93.2 Units on a Scale
Standard Deviation 13.9
Comfort
Irritation
90.2 Units on a Scale
Standard Deviation 14.1
92.9 Units on a Scale
Standard Deviation 10.6
Comfort
Itching
93.0 Units on a Scale
Standard Deviation 10.7
94.9 Units on a Scale
Standard Deviation 9.3
Comfort
Dryness
88.8 Units on a Scale
Standard Deviation 14.4
90.5 Units on a Scale
Standard Deviation 11.8
Comfort
Comfort
90.2 Units on a Scale
Standard Deviation 12.7
92.7 Units on a Scale
Standard Deviation 9.3
Comfort
End of Day Comfort
84.5 Units on a Scale
Standard Deviation 16.9
87.2 Units on a Scale
Standard Deviation 14.5

PRIMARY outcome

Timeframe: 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).

Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.

Outcome measures

Outcome measures
Measure
Marketed Bottle ReNu MultiPlus Multi-Purpose Solution
n=312 eyes
Currently Marketed high-density polyethylene (HDPE) Bottle with B\&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
Clear Bottle ReNu MultiPlus Multi-Purpose Solution
n=304 eyes
Clear polyethylene terephthalate (PET) Bottle with B\&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
Slit Lamp Findings
Slit Lamp Finding > Grade 2
1 Eyes
0 Eyes
Slit Lamp Findings
Slit Lamp Findings </= Grade 2
311 Eyes
304 Eyes

PRIMARY outcome

Timeframe: 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)

Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.

Outcome measures

Outcome measures
Measure
Marketed Bottle ReNu MultiPlus Multi-Purpose Solution
n=310 eyes
Currently Marketed high-density polyethylene (HDPE) Bottle with B\&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
Clear Bottle ReNu MultiPlus Multi-Purpose Solution
n=300 eyes
Clear polyethylene terephthalate (PET) Bottle with B\&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
Lens Deposits
Absent
292 Eyes
281 Eyes
Lens Deposits
Present
18 Eyes
19 Eyes

Adverse Events

Marketed Bottle ReNu MultiPlus Multi-Purpose Solution

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Clear Bottle ReNu MultiPlus Multi-Purpose Solution

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gerard Cairns

Bausch & Lomb Incorporated

Phone: (585) 338-5170

Results disclosure agreements

  • Principal investigator is a sponsor employee The results of the study may be published or presented by the investigator(s) after the review by, and in consultation and agreement with the Sponser, and such that confidential or proprietary information is not disclosed.
  • Publication restrictions are in place

Restriction type: OTHER