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Product Performance of a Toric Contact Lens

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ClinicalTrials.gov Identifier: NCT00658996
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : February 16, 2011
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Myopia
Astigmatism
Interventions Device: SofLens DD Toric
Device: Ciba Vision Focus Dailies Toric Contact Lens
Enrollment 220
Recruitment Details This 4-week study was conducted at 12 sites in Asia. First participant enrolled 4/16/08, last participant visit was 6/20/08
Pre-assignment Details 220 participants were enrolled in the study, 4 participants were ineligible at screening visit, 216 Subjects started the first intervention. 211 participants started the second intervention. 209 participants completed the study.
Arm/Group Title SofLens DD Toric First, Then Focus Dailies Toric Focus Dailies Toric First, Then SofLens DD Toric
Hide Arm/Group Description Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
Period Title: First Intervention
Started 109 107
Completed 108 106
Not Completed 1 1
Reason Not Completed
Positive slit lamp finding             1             0
Lack of lenses             0             1
Period Title: Crossover Period
Started 108 106
Completed 106 105
Not Completed 2 1
Reason Not Completed
Physician Decision             1             0
Ineligible             1             1
Period Title: Second Intervention
Started 106 105
Completed 105 104
Not Completed 1 1
Reason Not Completed
Developed a stye on upper lid             1             0
Positive slit lamp finding             0             1
Arm/Group Title Entire Study Population
Hide Arm/Group Description Population enrolled at start of study
Overall Number of Baseline Participants 216
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 216 participants
28.7  (7.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants
Female
150
  69.4%
Male
66
  30.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 216 participants
Asian 216
White 0
Black 0
Other 0
1.Primary Outcome
Title Symptoms and Complaints
Hide Description 1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Time Frame Over-all follow-up visits for 2 week period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible, dispensed eyes, Overall follow-up visits.
Arm/Group Title SofLens DD Toric Focus Dailies Toric
Hide Arm/Group Description:
Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
Ciba Vision Focus Dailies Toric contact lenses
Overall Number of Participants Analyzed 213 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
426 420
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Comfort 79.3  (17.1) 77.7  (17.6)
End of Day Comfort 73.5  (19.6) 71.5  (19.9)
Lens Awareness 78.8  (17.9) 75.6  (20.4)
Lens Cleanliness 87.5  (12.7) 86.5  (13.0)
Irritation 83.0  (15.6) 79.3  (19.6)
Itching 86.4  (14.9) 83.9  (17.2)
Dryness 77.4  (18.0) 73.7  (20.3)
Redness 86.3  (14.9) 81.5  (19.5)
Vision 77.1  (19.1) 84.3  (14.6)
Lens Handling 87.4  (13.0) 76.1  (21.2)
Overall Impression 78.7  (16.2) 75.9  (17.5)
2.Primary Outcome
Title Contact Lens High Contrast Visual Acuity
Hide Description VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test – Control) in overall logMAR VA.
Time Frame Over-all follow-up visits, 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible, dispensed eyes
Arm/Group Title SofLens DD Toric Focus Dailies Toric
Hide Arm/Group Description:
Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
Ciba Vision Focus Dailies Toric contact lenses
Overall Number of Participants Analyzed 213 210
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
426 420
Mean (Standard Deviation)
Unit of Measure: LogMAR
-0.007  (0.0669) -0.014  (0.0696)
3.Secondary Outcome
Title Slit Lamp Findings
Hide Description Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates
Time Frame Over-all follow-up visits, 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All dispensed eyes, over all follow-up visits
Arm/Group Title SofLens DD Toric Focus Dailies Toric
Hide Arm/Group Description:
Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
Ciba Vision Focus Dailies Toric contact lenses
Overall Number of Participants Analyzed 215 215
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
430 430
Measure Type: Number
Unit of Measure: Eyes
Slit Lamp Findings > Grade 2 0 2
Slit Lamp Findings </= Grade 2 430 428
Time Frame One month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SofLens DD Toric Ciba Vision Toric Lens
Hide Arm/Group Description Bausch & Lomb SofLens Daily Disposable Toric Contact Lens Ciba Vision Focus Dailies Toric Lens
All-Cause Mortality
SofLens DD Toric Ciba Vision Toric Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SofLens DD Toric Ciba Vision Toric Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/215 (0.00%)   0/216 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
SofLens DD Toric Ciba Vision Toric Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/215 (0.00%)   0/216 (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.
 
Results Point of Contact
Name/Title: Gerard Cairns, PhD, MCOptom
Organization: Bausch & Lomb Incorporated
Phone: (585) 338-5170
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00658996     History of Changes
Other Study ID Numbers: 559
First Submitted: April 12, 2008
First Posted: April 16, 2008
Results First Submitted: December 14, 2010
Results First Posted: February 16, 2011
Last Update Posted: December 12, 2011