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Trial Outcomes & Findings for A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution (NCT NCT01024751)

NCT ID: NCT01024751

Last Updated: 2011-08-15

Results Overview

Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

312 participants

Primary outcome timeframe

At dispensing visit and each follow-up visit at week 2 and week 4.

Results posted on

2011-08-15

Participant Flow

This one month study was conducted at 20 sites by 20 investigators in the United States. First participant was enrolled 11/30/2009 and last Participants visit was 1/22/2010.

312 participants(624 eyes) started the study, 7 of which were ineligible at baseline, one was non-dispensed. 305(610 eyes) participants were eligible. 3 participants were discontinued during the study. 302 participants (604 eyes) completed the study.

Participant milestones

Participant milestones
Measure
Bausch & Lomb Multi-Purpose Solution
Multi-Purpose Solution to be used for disinfecting contact lenses.
Ciba's Multi-Purpose Solution
Multi-Purpose Solution to be used for disinfecting contact lenses.
Enrolled Participants
STARTED
156
156
Enrolled Participants
COMPLETED
153
152
Enrolled Participants
NOT COMPLETED
3
4
Eligible Participants
STARTED
153
152
Eligible Participants
COMPLETED
153
149
Eligible Participants
NOT COMPLETED
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Bausch & Lomb Multi-Purpose Solution
Multi-Purpose Solution to be used for disinfecting contact lenses.
Ciba's Multi-Purpose Solution
Multi-Purpose Solution to be used for disinfecting contact lenses.
Enrolled Participants
Ineligible at baseline
3
4
Eligible Participants
Withdrawal by Subject
0
1
Eligible Participants
Lost to Follow-up
0
1
Eligible Participants
Ineligible
0
1

Baseline Characteristics

A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Bausch & Lomb Multi-Purpose Solution
n=153 Participants
Multi-Purpose Solution to be used for disinfecting contact lenses.
Ciba's Multi-Purpose Solution
n=152 Participants
Multi-Purpose Solution to be used for disinfecting contact lenses.
Total
n=305 Participants
Total of all reporting groups
Age, Customized
Between 18 and 70 years
153 participants
n=5 Participants
152 participants
n=7 Participants
305 participants
n=5 Participants
Sex: Female, Male
Female
102 Participants
n=5 Participants
112 Participants
n=7 Participants
214 Participants
n=5 Participants
Sex: Female, Male
Male
51 Participants
n=5 Participants
40 Participants
n=7 Participants
91 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
14 Participants
n=5 Participants
15 Participants
n=7 Participants
29 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
Race (NIH/OMB)
White
131 Participants
n=5 Participants
126 Participants
n=7 Participants
257 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants

PRIMARY outcome

Timeframe: At dispensing visit and each follow-up visit at week 2 and week 4.

Population: Summaries included all eligible, dispensed participants, with participants summarized under the study products received.

Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.

Outcome measures

Outcome measures
Measure
Bausch & Lomb Multi-Purpose Solution
n=306 eyes
Multi-Purpose Solution to be used for disinfecting contact lenses.
Ciba's Multi-Purpose Solution
n=302 eyes
Multi-Purpose Solution to be used for disinfecting contact lenses.
Comfort-related Symptoms/Complaints
Comfort
89.0 Units on a scale
Standard Deviation 14.2
88.3 Units on a scale
Standard Deviation 14.7
Comfort-related Symptoms/Complaints
End of Day Comfort
81.7 Units on a scale
Standard Deviation 20.7
81.9 Units on a scale
Standard Deviation 17.4
Comfort-related Symptoms/Complaints
Redness
90.7 Units on a scale
Standard Deviation 16.4
92.8 Units on a scale
Standard Deviation 13.0
Comfort-related Symptoms/Complaints
Burning/stinging upon insertion
91.4 Units on a scale
Standard Deviation 15.6
93.1 Units on a scale
Standard Deviation 14.0
Comfort-related Symptoms/Complaints
Irritation
88.2 Units on a scale
Standard Deviation 17.1
89.3 Units on a scale
Standard Deviation 14.1
Comfort-related Symptoms/Complaints
Itching
91.2 Units on a scale
Standard Deviation 15.8
94.3 Units on a scale
Standard Deviation 10.3
Comfort-related Symptoms/Complaints
Dryness
84.9 Units on a scale
Standard Deviation 20.6
85.4 Units on a scale
Standard Deviation 15.8

SECONDARY outcome

Timeframe: Over all visits for 1 month

Population: Greater than grade 2 for all dispensed eyes with non-missing scores

Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.

Outcome measures

Outcome measures
Measure
Bausch & Lomb Multi-Purpose Solution
n=312 eyes
Multi-Purpose Solution to be used for disinfecting contact lenses.
Ciba's Multi-Purpose Solution
n=153 Participants
Multi-Purpose Solution to be used for disinfecting contact lenses.
Slit Lamp Findings
1 eyes
3 eyes

Adverse Events

Bausch & Lomb Multi-Purpose Solution

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

Ciba's 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

William Reindel, OD, MS

Bausch & Lomb Incorporated

Phone: (585) 338-8129

Results disclosure agreements

  • Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. 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 Sponsor.
  • Publication restrictions are in place

Restriction type: OTHER