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Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

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ClinicalTrials.gov Identifier: NCT01791517
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : November 6, 2017
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: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Contact Lens Solutions
Interventions Other: Solution 1 (Test)
Other: Solution 2 (Test)
Other: Solution 3 (Test)
Other: Solution 4 (Control)
Enrollment 269
Recruitment Details A total of 269 Subjects were enrolled into this study. Of the enrolled 33 subjects did not meet the eligibility criteria. In Phase I 28 subjects were discontinued and 208 subjects completed Phase I. Of the 208 subjects that continued into Phase II 187 subjects completed the study and 21 subjects were discontinued from the from Phase II.
Pre-assignment Details Subjects were first randomized to 1 of 3 lenses(Lens A: senofilcon A, Lens B: galyfilcon A, Lens C: etafilcon A), then within each lens subjects were randomized to 1 of 12 unique solution sequences, totaling in 36 sequences. Due to such a large number of sequences for reporting purposes, subject disposition is reported by solution and period.
Arm/Group Title Biotrue/PureMoist/Revitalens/Clear Care Biotrue/RevitaLens/Clear Care/PureMoist Biotrue/Clear Care/PureMoist/RevitaLens PureMoist/Biotrue/Clear Care/RevitaLens PureMoist/RevitaLens/Biotrue/Clear Care PureMoist/Clear Care/RevitaLens/Biotrue RevitaLens/Biotrue/PureMoist/Clear Care RevitaLens/PureMoist/Clear Care/Biotrue RevitaLens/Clear Care/Biotrue/PureMoist Clear Care/Biotrue/RevitaLens/PureMoist Clear Care/PureMoist/Biotrue/RevitaLens Clear Care/RevitaLens/PureMoist/Biotrue
Hide Arm/Group Description Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences. Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
Period Title: Phase I: Period 1
Started 19 20 20 19 20 20 20 20 20 20 18 20
Completed 18 18 18 17 19 19 19 20 19 19 18 19
Not Completed 1 2 2 2 1 1 1 0 1 1 0 1
Reason Not Completed
Withdrawal by Subject             0             1             1             0             1             1             0             0             0             0             0             0
Adverse Event             0             0             1             1             0             0             0             0             0             0             0             0
Unsatisfactory Lens Fitting             1             0             0             0             0             0             0             0             0             0             0             0
Protocol Violation             0             1             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             1             0             0             1             0             1             1             0             0
Lens Handling DIfficulties             0             0             0             0             0             0             0             0             0             0             0             1
Period Title: Phase I: Period 2
Started 18 18 18 17 19 19 19 20 19 19 18 19
Completed 17 15 16 16 19 18 19 20 19 18 16 19
Not Completed 1 3 2 1 0 1 0 0 0 1 2 0
Reason Not Completed
Unsatisfactory Lens Fit             1             0             0             0             0             0             0             0             0             0             0             0
Protocol Violation             0             0             0             1             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             1             1             0
Unsatisfactory Visual Response             0             0             0             0             0             0             0             0             0             0             1             0
Lens Discomfort             0             0             0             0             0             1             0             0             0             0             0             0
Lost to Follow-up             0             3             2             0             0             0             0             0             0             0             0             0
Period Title: Phase I: Period 3
Started 17 15 16 16 19 18 19 20 19 18 16 19
Completed 17 14 16 15 18 18 19 20 19 18 16 18
Not Completed 0 1 0 1 1 0 0 0 0 0 0 1
Reason Not Completed
Lens Discomfort             0             0             0             0             0             0             0             0             0             0             0             1
Lost to Follow-up             0             1             0             0             1             0             0             0             0             0             0             0
Adverse Event             0             0             0             1             0             0             0             0             0             0             0             0
Period Title: Phase I: Period 4
Started 17 14 16 15 18 18 19 20 19 18 16 18
Completed 17 14 16 15 18 18 19 20 19 18 16 18
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Phase II
Started 17 14 16 15 18 18 19 20 19 18 16 18
Completed 15 14 15 15 16 14 17 17 17 15 15 17
Not Completed 2 0 1 0 2 4 2 3 2 3 1 1
Reason Not Completed
Lost to Follow-up             1             0             1             0             1             2             0             1             1             1             0             0
Withdrawal by Subject             1             0             0             0             0             2             0             1             0             0             1             0
Lack of Efficacy             0             0             0             0             1             0             0             0             0             0             0             0
Adverse Event             0             0             0             0             0             0             2             1             0             1             0             0
Lens Handling Difficulties             0             0             0             0             0             0             0             0             1             0             0             0
Unsatisfactory Lens Fitting             0             0             0             0             0             0             0             0             0             1             0             0
Pre-Existing Ocular Issue             0             0             0             0             0             0             0             0             0             0             0             1
Arm/Group Title Etafilcon A Galyfilcon A Senofilcon A Total
Hide Arm/Group Description All subjects that were randomized to the study lens etafilcon A and 1 of 12 possible solution sequences. All subjects that were randomized to the study lens galyfilcon A and 1 of 12 possible solution sequences. All subjects that were randomized to the study lens senofilcon A and 1 of 12 possible solution sequences. Total of all reporting groups
Overall Number of Baseline Participants 80 78 78 236
Hide Baseline Analysis Population Description
The analysis population consists of subjects that were randomized to 1 of 3 study lenses and 1 of 12 solution sequences.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 78 participants 78 participants 236 participants
30.33  (9.726) 30.38  (10.091) 29.78  (9.938) 30.17  (9.879)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 78 participants 236 participants
Female
55
  68.8%
50
  64.1%
53
  67.9%
158
  66.9%
Male
25
  31.3%
28
  35.9%
25
  32.1%
78
  33.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 78 participants 236 participants
Asian
18
  22.5%
18
  23.1%
22
  28.2%
58
  24.6%
Black or African American
9
  11.3%
5
   6.4%
6
   7.7%
20
   8.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.4%
White
52
  65.0%
45
  57.7%
43
  55.1%
140
  59.3%
Other
1
   1.3%
10
  12.8%
6
   7.7%
17
   7.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 78 participants 236 participants
Canada
28
  35.0%
26
  33.3%
26
  33.3%
80
  33.9%
United States
26
  32.5%
24
  30.8%
27
  34.6%
77
  32.6%
United Kingdom
26
  32.5%
28
  35.9%
25
  32.1%
79
  33.5%
1.Primary Outcome
Title Overall Comfort Score (Senofilcon A Lens)
Hide Description CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Time Frame 2-Week Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
Arm/Group Title Solution 1(RevitaLens) Solution 2(PureMoist) Solution 3(Biotrue) Solution 4(Clear Care)
Hide Arm/Group Description:
Subjects that received solution 1 during any of the 4 study periods.
Subjects that received solution 2 during any of the 4 study periods.
Subjects that received solution 3 during any of the 4 study periods.
Subjects that received solution 4 during any of the 4 study periods.
Overall Number of Participants Analyzed 69 69 69 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
64.42  (22.536) 59.73  (25.470) 63.75  (21.796) 63.47  (23.739)
2.Primary Outcome
Title Overall Comfort Score (Galyfilcon A Lens)
Hide Description CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Time Frame 2-Week Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
Arm/Group Title Solution 1(RevitaLens) Solution 2(PureMoist) Solution 3(Biotrue) Solution 4(Clear Care)
Hide Arm/Group Description:
Subjects that received solution 1 during any of the 4 study periods.
Subjects that received solution 2 during any of the 4 study periods.
Subjects that received solution 3 during any of the 4 study periods.
Subjects that received solution 4 during any of the 4 study periods.
Overall Number of Participants Analyzed 69 69 69 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
59.79  (23.430) 56.95  (24.679) 58.52  (22.197) 59.83  (22.437)
3.Primary Outcome
Title Overall Comfort Score (Etafilcon A Lens)
Hide Description CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Time Frame 2-Week Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
Arm/Group Title Solution 1(RevitaLens) Solution 2(PureMoist) Solution 3(Biotrue) Solution 4(Clear Care)
Hide Arm/Group Description:
Subjects that received solution 1 during any of the 4 study periods.
Subjects that received solution 2 during any of the 4 study periods.
Subjects that received solution 3 during any of the 4 study periods.
Subjects that received solution 4 during any of the 4 study periods.
Overall Number of Participants Analyzed 65 65 65 65
Mean (Standard Deviation)
Unit of Measure: units on a scale
62.57  (25.158) 67.44  (19.65) 62.43  (21.492) 65.33  (21.163)
Time Frame Throughout the duration of the study. Approximately 52 weeks.
Adverse Event Reporting Description Adverse events from Phase I and Phase II are reported together due to the large number of lens and solution combinations.
 
Arm/Group Title Solution 1(RevitaLens): Senofilcon A Solution 1 (RevitaLens): Galyfilcon A Solution 1(RevitaLens): Etafilcon A Solution 2(PureMoist):Senofilcon A Solution 2(PureMoist): Galyfilcon A Solution 2(PureMoist): Etafilcon A Solution 3(Biotrue): Senofilcon A Solution 3(Biotrue): Galyfilcon A Solution 3(Biotrue): Etafilcon A Solution 4(Clear Care): Senofilcon A Solution 4(Clear Care): Galyfilcon A Solution 4(Clear Care): Etafilcon A
Hide Arm/Group Description Subjects that were randomized to the senofilcon A lens and received solution 1 during any of the 4 study periods. Subjects that were randomized to the galyfilcon A lens and received solution 1 during any of the 4 study periods. Subjects that were randomized to the etafilcon A lens and received solution 1 during any of the 4 study periods. Subjects were randomized to the senofilcon A lens and that received solution 2 during any of the 4 study periods. Subjects were randomized to the galyfilcon A lens and that received solution 2 during any of the 4 study periods. Subjects were randomized to the etafilcon A lens and that received solution 2 during any of the 4 study periods. Subjects that were randomized to the senofilcon A lens and received solution 3 during any of the 4 study periods. Subjects that were randomized to the galyfilcon A lens and received solution 3 during any of the 4 study periods. Subjects that were randomized to the etafilcon A lens and received solution 3 during any of the 4 study periods. Subjects that were randomized to the senofilcon A lens and received solution 4 during any of the 4 study periods. Subjects that were randomized to the galyfilcon A lens and received solution 4 during any of the 4 study periods. Subjects that were randomized to the etafilcon A lens and received solution 4 during any of the 4 study periods.
All-Cause Mortality
Solution 1(RevitaLens): Senofilcon A Solution 1 (RevitaLens): Galyfilcon A Solution 1(RevitaLens): Etafilcon A Solution 2(PureMoist):Senofilcon A Solution 2(PureMoist): Galyfilcon A Solution 2(PureMoist): Etafilcon A Solution 3(Biotrue): Senofilcon A Solution 3(Biotrue): Galyfilcon A Solution 3(Biotrue): Etafilcon A Solution 4(Clear Care): Senofilcon A Solution 4(Clear Care): Galyfilcon A Solution 4(Clear Care): Etafilcon A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Solution 1(RevitaLens): Senofilcon A Solution 1 (RevitaLens): Galyfilcon A Solution 1(RevitaLens): Etafilcon A Solution 2(PureMoist):Senofilcon A Solution 2(PureMoist): Galyfilcon A Solution 2(PureMoist): Etafilcon A Solution 3(Biotrue): Senofilcon A Solution 3(Biotrue): Galyfilcon A Solution 3(Biotrue): Etafilcon A Solution 4(Clear Care): Senofilcon A Solution 4(Clear Care): Galyfilcon A Solution 4(Clear Care): Etafilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/78 (1.28%)      0/78 (0.00%)      0/80 (0.00%)      0/78 (0.00%)      0/78 (0.00%)      0/80 (0.00%)      1/78 (1.28%)      0/78 (0.00%)      1/80 (1.25%)      1/78 (1.28%)      0/78 (0.00%)      0/80 (0.00%)    
Infections and infestations                         
Retro-peritoneal abscess in the kidney area. [1]  1/78 (1.28%)  1 0/78 (0.00%)  0 0/80 (0.00%)  0 0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0 0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0 0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0
Viral Meningitis [2]  0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0 0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0 1/78 (1.28%)  1 0/78 (0.00%)  0 0/80 (0.00%)  0 0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0
Nervous system disorders                         
Seizure [3]  0/78 (0.00%)  0/78 (0.00%)  0/80 (0.00%)  0/78 (0.00%)  0/78 (0.00%)  0/80 (0.00%)  0/78 (0.00%)  0/78 (0.00%)  1/80 (1.25%)  2 0/78 (0.00%)  0/78 (0.00%)  0/80 (0.00%) 
Psychiatric disorders                         
Mental Health / Phychiatric Hospital Admission [4]  0/78 (0.00%)  0/78 (0.00%)  0/80 (0.00%)  0/78 (0.00%)  0/78 (0.00%)  0/80 (0.00%)  0/78 (0.00%)  0/78 (0.00%)  1/80 (1.25%)  1 0/78 (0.00%)  0/78 (0.00%)  0/80 (0.00%) 
Surgical and medical procedures                         
Reconstructive Surgery on Left Upper Arm [5]  0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0 0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0 0/78 (0.00%)  0 0/78 (0.00%)  0 0/80 (0.00%)  0 1/78 (1.28%)  1 0/78 (0.00%)  0 0/80 (0.00%)  0
[1]
According to the participant, his doctors hypothesized that the development of the abscess may be related to a perforated appendix he had in November 2011. This adverse event was deemed unrelated to the study by the investigator.
[2]
Suspect viral meningitis. Had severe vomiting and headaches. Subject admitted to hospital. This was deemed unrelated to the study by the investigator.
[3]
Subject experienced two seizures, on August 03, 2013 to August 04, 2013. Subject has a history of seizures and stopped taking medicine(without doctor's approval). The adverse event was deemed unrelated to the study by the investigator.
[4]
Subject's discontinuation of seizure medication and mental health status and was admitted to the hospital on August 03, 2013. The adverse event was deemed unrelated to the study by the investigator.
[5]
This event was deemed unrelated to the study by the investigator.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Solution 1(RevitaLens): Senofilcon A Solution 1 (RevitaLens): Galyfilcon A Solution 1(RevitaLens): Etafilcon A Solution 2(PureMoist):Senofilcon A Solution 2(PureMoist): Galyfilcon A Solution 2(PureMoist): Etafilcon A Solution 3(Biotrue): Senofilcon A Solution 3(Biotrue): Galyfilcon A Solution 3(Biotrue): Etafilcon A Solution 4(Clear Care): Senofilcon A Solution 4(Clear Care): Galyfilcon A Solution 4(Clear Care): Etafilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/78 (0.00%)      0/78 (0.00%)      0/80 (0.00%)      0/78 (0.00%)      0/78 (0.00%)      0/80 (0.00%)      0/78 (0.00%)      0/78 (0.00%)      0/80 (0.00%)      0/78 (0.00%)      0/78 (0.00%)      0/80 (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: Chantal Coles-Brennan, PRINCIPAL RESEARCH OPTOMETRIST, Global Med Affairs
Organization: Johnson & Johnson Vision Care, Inc.
Phone: 904-443-3500 ext 3449
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01791517     History of Changes
Other Study ID Numbers: CR-5230
First Submitted: February 11, 2013
First Posted: February 15, 2013
Results First Submitted: August 16, 2017
Results First Posted: November 6, 2017
Last Update Posted: June 19, 2018