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Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution

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ClinicalTrials.gov Identifier: NCT00636194
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : February 15, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Adverse Effect of Contact Lens Solution
Interventions Device: Bausch & Lomb Multipurpose Solution
Device: Alcon OptiFree Replenish Multipurpose Solution
Enrollment 361
Recruitment Details 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.
Pre-assignment Details 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
Arm/Group Title B&L Multipurpose Solution Alcon Multipurpose Solution
Hide Arm/Group Description Bausch & Lomb Multipurpose Contact Lens Solution Alcon OptiFree Replenish Multipurpose Contact Lens Solution
Period Title: Overall Study
Started 175 175
Completed 172 175
Not Completed 3 0
Reason Not Completed
Study related symptoms and complaints             1             0
Protocol Violation             2             0
Arm/Group Title B&L Multipurpose Solution Alcon Multipurpose Solution Total
Hide Arm/Group Description Bausch & Lomb Multipurpose Contact Lens Solution Alcon OptiFree Replenish Multipurpose Contact Lens Solution Total of all reporting groups
Overall Number of Baseline Participants 175 175 350
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
175
 100.0%
175
 100.0%
350
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
Female
125
  71.4%
121
  69.1%
246
  70.3%
Male
50
  28.6%
54
  30.9%
104
  29.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 175 participants 175 participants 350 participants
175 175 350
1.Primary Outcome
Title Subjective Assessment of Comfort and Cleanliness
Hide Description Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
All eyes
Arm/Group Title B&L Multipurpose Solution Alcon Multipurpose Solution
Hide Arm/Group Description:
Bausch & Lomb Multipurpose Contact Lens Solution
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
Overall Number of Participants Analyzed 174 175
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
348 350
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Cleanliness upon insertion 89.71  (14.52) 89.26  (14.52)
Comfort upon insertion 87.45  (15.56) 86.63  (15.56)
Cleanliness at end of day 82.98  (18.54) 82.34  (18.54)
Comfort at end of day 80.14  (19.41) 79.60  (19.41)
2.Secondary Outcome
Title Symptoms and Complaints
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible, dispensed eyes
Arm/Group Title B&L Multipurpose Solution Alcon Multipurpose Solution
Hide Arm/Group Description:
Bausch & Lomb Multipurpose Contact Lens Solution
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
Overall Number of Participants Analyzed 173 175
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
346 350
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Comfort 85.4  (14.7) 86.1  (13.1)
End of day comfort 79.2  (16.7) 79.3  (15.1)
Burning/stinging upon insertion 87.0  (18.7) 88.9  (14.8)
Irritation 86.4  (18.7) 88.2  (14.6)
Itching 89.2  (16.6) 90.3  (13.2)
Dryness 80.6  (16.6) 81.9  (15.7)
Redness 89.2  (15.8) 90.0  (12.7)
Vision 89.8  (13.1) 89.4  (12.5)
Lens cleanliness 86.6  (14.6) 86.9  (13.1)
Lens handling 90.8  (11.4) 90.4  (11.0)
3.Secondary Outcome
Title Graded Slit Lamp Findings > Grade 2
Hide Description 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.
Time Frame 2 week follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
All dispensed, completed eyes
Arm/Group Title B&L Multipurpose Solution Alcon Multipurpose Solution
Hide Arm/Group Description:
Bausch & Lomb Multipurpose Contact Lens Solution
Alcon OptiFree Replenish Multipurpose Contact Lens Solution
Overall Number of Participants Analyzed 172 175
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
344 350
Measure Type: Number
Unit of Measure: eyes
Epithelial edema 0 0
Epithelial microcysts 0 0
Corneal staining 3 0
Limbal injection 0 0
Bulbar injection 0 0
Superior tarsal conjunctival abnormalities 0 0
Corneal neovascularization 0 0
Corneal infiltrates 0 0
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title B&L Multipurpose Solution Alcon Multipurpose Solution
Hide Arm/Group Description Bausch & Lomb Multipurpose Contact Lens Solution Alcon OptiFree Replenish Multipurpose Contact Lens Solution
All-Cause Mortality
B&L Multipurpose Solution Alcon Multipurpose Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
B&L Multipurpose Solution Alcon Multipurpose Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/175 (0.00%)   0/175 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
B&L Multipurpose Solution Alcon Multipurpose Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/175 (0.00%)   0/175 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is 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, 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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Steffen OD
Organization: Bausch & Lomb
Phone: (585) 338-6399
EMail: robert.steffen@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00636194     History of Changes
Other Study ID Numbers: 562
First Submitted: March 7, 2008
First Posted: March 14, 2008
Results First Submitted: December 14, 2010
Results First Posted: February 15, 2011
Last Update Posted: December 13, 2011