Trial Outcomes & Findings for Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution (NCT NCT00636194)
NCT ID: NCT00636194
Last Updated: 2011-12-13
Results Overview
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
361 participants
Primary outcome timeframe
7 days
Results posted on
2011-12-13
Participant Flow
361 subjects (722 eyes) who are currently adapted silicone hydrogel contact lens wearers and are habitually using a lens care product for disinfecting lenses, were enrolled in this 2-Week study at approximately 14 investigative sites in Asia. Study start date was 2/16/2008 and last subject exited on 3/17/2008.
Fourteen Investigators enrolled 361 subjects in the study. Of these subjects, 347 successfully completed the study, 3 discontinued and 11 were ineligible at baseline, but were dispensed study materials
Participant milestones
| Measure |
B&L Multipurpose Solution
Bausch \& Lomb Multipurpose Contact Lens Solution
|
Alcon Multipurpose Solution
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
|
Overall Study
COMPLETED
|
172
|
175
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
B&L Multipurpose Solution
Bausch \& Lomb Multipurpose Contact Lens Solution
|
Alcon Multipurpose Solution
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
|
|---|---|---|
|
Overall Study
Study related symptoms and complaints
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution
Baseline characteristics by cohort
| Measure |
B&L Multipurpose Solution
n=175 Participants
Bausch \& Lomb Multipurpose Contact Lens Solution
|
Alcon Multipurpose Solution
n=175 Participants
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
175 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
175 participants
n=5 Participants
|
175 participants
n=7 Participants
|
350 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: All eyes
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
Outcome measures
| Measure |
B&L Multipurpose Solution
n=348 eyes
Bausch \& Lomb Multipurpose Contact Lens Solution
|
Alcon Multipurpose Solution
n=350 eyes
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
|
|---|---|---|
|
Subjective Assessment of Comfort and Cleanliness
Cleanliness upon insertion
|
89.71 Scores on a scale
Standard Deviation 14.52
|
89.26 Scores on a scale
Standard Deviation 14.52
|
|
Subjective Assessment of Comfort and Cleanliness
Comfort upon insertion
|
87.45 Scores on a scale
Standard Deviation 15.56
|
86.63 Scores on a scale
Standard Deviation 15.56
|
|
Subjective Assessment of Comfort and Cleanliness
Cleanliness at end of day
|
82.98 Scores on a scale
Standard Deviation 18.54
|
82.34 Scores on a scale
Standard Deviation 18.54
|
|
Subjective Assessment of Comfort and Cleanliness
Comfort at end of day
|
80.14 Scores on a scale
Standard Deviation 19.41
|
79.60 Scores on a scale
Standard Deviation 19.41
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All eligible, dispensed eyes
Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.
Outcome measures
| Measure |
B&L Multipurpose Solution
n=346 eyes
Bausch \& Lomb Multipurpose Contact Lens Solution
|
Alcon Multipurpose Solution
n=350 eyes
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
|
|---|---|---|
|
Symptoms and Complaints
Vision
|
89.8 Score on a scale
Standard Deviation 13.1
|
89.4 Score on a scale
Standard Deviation 12.5
|
|
Symptoms and Complaints
Comfort
|
85.4 Score on a scale
Standard Deviation 14.7
|
86.1 Score on a scale
Standard Deviation 13.1
|
|
Symptoms and Complaints
End of day comfort
|
79.2 Score on a scale
Standard Deviation 16.7
|
79.3 Score on a scale
Standard Deviation 15.1
|
|
Symptoms and Complaints
Burning/stinging upon insertion
|
87.0 Score on a scale
Standard Deviation 18.7
|
88.9 Score on a scale
Standard Deviation 14.8
|
|
Symptoms and Complaints
Irritation
|
86.4 Score on a scale
Standard Deviation 18.7
|
88.2 Score on a scale
Standard Deviation 14.6
|
|
Symptoms and Complaints
Itching
|
89.2 Score on a scale
Standard Deviation 16.6
|
90.3 Score on a scale
Standard Deviation 13.2
|
|
Symptoms and Complaints
Dryness
|
80.6 Score on a scale
Standard Deviation 16.6
|
81.9 Score on a scale
Standard Deviation 15.7
|
|
Symptoms and Complaints
Redness
|
89.2 Score on a scale
Standard Deviation 15.8
|
90.0 Score on a scale
Standard Deviation 12.7
|
|
Symptoms and Complaints
Lens cleanliness
|
86.6 Score on a scale
Standard Deviation 14.6
|
86.9 Score on a scale
Standard Deviation 13.1
|
|
Symptoms and Complaints
Lens handling
|
90.8 Score on a scale
Standard Deviation 11.4
|
90.4 Score on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 2 week follow-up visitPopulation: All dispensed, completed eyes
Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.
Outcome measures
| Measure |
B&L Multipurpose Solution
n=344 eyes
Bausch \& Lomb Multipurpose Contact Lens Solution
|
Alcon Multipurpose Solution
n=350 eyes
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
|
|---|---|---|
|
Graded Slit Lamp Findings > Grade 2
Corneal infiltrates
|
0 eyes
|
0 eyes
|
|
Graded Slit Lamp Findings > Grade 2
Epithelial edema
|
0 eyes
|
0 eyes
|
|
Graded Slit Lamp Findings > Grade 2
Epithelial microcysts
|
0 eyes
|
0 eyes
|
|
Graded Slit Lamp Findings > Grade 2
Corneal staining
|
3 eyes
|
0 eyes
|
|
Graded Slit Lamp Findings > Grade 2
Limbal injection
|
0 eyes
|
0 eyes
|
|
Graded Slit Lamp Findings > Grade 2
Bulbar injection
|
0 eyes
|
0 eyes
|
|
Graded Slit Lamp Findings > Grade 2
Superior tarsal conjunctival abnormalities
|
0 eyes
|
0 eyes
|
|
Graded Slit Lamp Findings > Grade 2
Corneal neovascularization
|
0 eyes
|
0 eyes
|
Adverse Events
B&L Multipurpose Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcon Multipurpose 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
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 Sponsor, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee, for comment.
- Publication restrictions are in place
Restriction type: OTHER