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Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

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ClinicalTrials.gov Identifier: NCT00762502
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : November 25, 2014
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Astigmatism
Interventions Device: senofilcon A toric contact lens
Device: balafilcon A toric contact lens
Enrollment 112
Recruitment Details Recruitment occurred at 1 site in the USA (n=50 enrolled), and 7 sites in Australia (n=62 enrolled)
Pre-assignment Details Total of 112 subjects enrolled, 77 subjects completed study after 3 months. The study was then restricted down to two sites (Australia only) after 3 months with only 37 of the 77 being included. There were 36 subjects whom completed the full 6 month trial period.
Arm/Group Title Senofilcon A Bilaterally Balafilcon A Bilaterally Senofilcon A Toric/Balafilcon A Toric Contralaterally
Hide Arm/Group Description Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated. Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated. Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
Period Title: Baseline to Month 3 (Period 1)
Started 36 25 51
Completed 26 19 32
Not Completed 10 6 19
Reason Not Completed
Adverse Event             4             3             6
Lost to Follow-up             6             3             13
Period Title: Month 3 to Month 6 (Period 2)
Started 9 5 23
Completed 9 4 23
Not Completed 0 1 0
Reason Not Completed
Pregnancy             0             1             0
Arm/Group Title Senofilcon A Toric Bilaterally Balafilcon A Toric Bilaterally Senofilcon A/Balafilcon A Contralaterally Total
Hide Arm/Group Description senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. Total of all reporting groups
Overall Number of Baseline Participants 36 25 51 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 25 participants 51 participants 112 participants
29.8  (6.9) 30.4  (7.8) 29.6  (8.6) 29.8  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 25 participants 51 participants 112 participants
Female
25
  69.4%
19
  76.0%
35
  68.6%
79
  70.5%
Male
11
  30.6%
6
  24.0%
16
  31.4%
33
  29.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 25 participants 51 participants 112 participants
United States 16 11 20 47
Australia 20 14 31 65
1.Primary Outcome
Title Corneal Staining
Hide Description Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Time Frame at 3 months of lens wear (period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
Arm/Group Title Senofilcon A Balafilcon A
Hide Arm/Group Description:
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
Overall Number of Participants Analyzed 42 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
68 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (0.61) 0.8  (0.74)
2.Primary Outcome
Title Limbal Redness
Hide Description Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Time Frame at 3 months of lens wear (period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
Arm/Group Title Senofilcon A Balafilcon A
Hide Arm/Group Description:
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
Overall Number of Participants Analyzed 42 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
68 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.7  (0.61) 0.7  (0.58)
3.Primary Outcome
Title Bulbar Redness
Hide Description Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Time Frame at 3 months of lens wear (period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
Arm/Group Title Senofilcon A Balafilcon A
Hide Arm/Group Description:
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
Overall Number of Participants Analyzed 42 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
68 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.9  (0.58) 0.8  (0.57)
4.Primary Outcome
Title Tarsal Roughness
Hide Description Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Time Frame at 3 months of lens wear (period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
Arm/Group Title Senofilcon A Balafilcon A
Hide Arm/Group Description:
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
Overall Number of Participants Analyzed 42 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
68 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (0.58) 1.0  (0.75)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Senofilcon A Balafilcon A
Hide Arm/Group Description senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow. balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
All-Cause Mortality
Senofilcon A Balafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Senofilcon A Balafilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/87 (0.00%)      1/76 (1.32%)    
Eye disorders     
Microbial Karatitis   0/87 (0.00%)  0 1/76 (1.32%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Senofilcon A Balafilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/87 (14.94%)      9/76 (11.84%)    
Eye disorders     
Non-Significant Events  [1]  13/87 (14.94%)  13 9/76 (11.84%)  9
Indicates events were collected by systematic assessment
[1]
These were reported non-specifically as a single category of non-significant events.
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.
Publication requires agreement and written consent from the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Buch, OD
Organization: Johnson & Johnson Vision Care, Inc.
Phone: 1-904-443-1707
EMail: RA-Visus-ClnclStds@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00762502    
Other Study ID Numbers: CR-4498
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: March 28, 2014
Results First Posted: November 25, 2014
Last Update Posted: June 19, 2018