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Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

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ClinicalTrials.gov Identifier: NCT01055132
Recruitment Status : Completed
First Posted : January 25, 2010
Results First Posted : February 7, 2013
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: Single (Participant);   Primary Purpose: Treatment
Condition Astigmatism
Interventions Device: Etafilcon A toric contact lens
Device: Nelfilcon A toric contact lens
Enrollment 70
Recruitment Details  
Pre-assignment Details One subject failed screening, and did not enter group assignment
Arm/Group Title Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second
Hide Arm/Group Description Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
Period Title: Period 1 (5-9 Days)
Started 36 33
Completed 35 33
Not Completed 1 0
Reason Not Completed
unsatisfactory lens fitting performance             1             0
Period Title: Period 2 (5-9 Days)
Started 35 33
Completed 35 32
Not Completed 0 1
Reason Not Completed
Unsatisfactory lens fitting performance             0             1
Arm/Group Title All Subjects
Hide Arm/Group Description All subjects who completed the study.
Overall Number of Baseline Participants 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants
29.1  (5.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants
Female
45
  65.2%
Male
24
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 69 participants
69
1.Primary Outcome
Title Monocular Visual Acuity on LogMAR Scale
Hide Description Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Time Frame After 5 to 9 days of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on subjects who successfully complete the study.
Arm/Group Title Etafilcon A Toric (Test Lens) Nelfilcon A Toric (Active Comparator)
Hide Arm/Group Description:
Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
An existing, daily disposable toric contact lens; worn 5-9 days
Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: logMAR
-0.065  (0.0777) -0.038  (0.1057)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A Toric (Test Lens), Nelfilcon A Toric (Active Comparator)
Comments Ho:The test lens is non-inferior to the active comparator lens for monocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Based on historical data, a minimum of 42 subjects is needed to achieve 80% power with 0.05 type I error.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method linear mixed model
Comments Sequence of wear, period and lens were included as fixed effects; site, patient, eye*patient, period*patient and period*eye*patient as random effects.
Method of Estimation Estimation Parameter Least-square mean difference
Estimated Value -0.037
Confidence Interval (2-Sided) 95%
-0.041 to -0.0013
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0072
Estimation Comments Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference(test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.
2.Primary Outcome
Title Binocular Visual Acuity on LogMAR Scale
Hide Description Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Time Frame After 5 to 9 days of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on subjects who successfully complete the study.
Arm/Group Title Etafilcon A Toric (Test Lens) Nelfilcon A Toric Lens (Active Comparator)
Hide Arm/Group Description:
Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
An existing, daily disposable toric contact lens; worn 5-9 days
Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: LogMAR
-0.122  (0.0718) -0.108  (0.0766)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A Toric (Test Lens), Nelfilcon A Toric Lens (Active Comparator)
Comments Ho:The test lens is non-inferior to the active comparator lens for Binocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method linear mixed model
Comments Sequence of wear,lens period and lens were included in the model as fixed effects; site, patient, period*patient were included as random effects.
Method of Estimation Estimation Parameter Least-square mean difference
Estimated Value -0.015
Confidence Interval (2-Sided) 95%
-0.027 to -0.003
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0062
Estimation Comments Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.
3.Primary Outcome
Title Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
Hide Description The Contact Lens User Evaluation(CLUE)TM questionnaire 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 +/-3*SD).
Time Frame After 5 to 9 days of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on subjects who successfully complete the study.
Arm/Group Title Etafilcon A (Test Lens) Nelfilcon A (Active Comparator)
Hide Arm/Group Description:
Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn 5-9 days
An existing, daily disposable toric contact lens; worn for 5-9 days
Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
56.4  (9.12) 44.0  (9.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A (Test Lens), Nelfilcon A (Active Comparator)
Comments Ho:The test lens is non-inferior to the active comparator lens for comfort at 1-week follow-up. A non-inferiority margin of -5 units was used.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method linear mixed model
Comments Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and Site and patient as random effects.
Method of Estimation Estimation Parameter Least-square mean difference
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
4.05 to 19.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.93
Estimation Comments Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.
4.Primary Outcome
Title Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
Hide Description The Contact Lens User Evaluation(CLUE)TM questionnaire 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 +/-3*SD).
Time Frame After 5 to 9 days of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on subjects who successfully complete the study.
Arm/Group Title Etafilcon A (Test Lens) Nelfilcon A (Active Comparator)
Hide Arm/Group Description:
Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
An existing, daily disposable toric contact lens; worn for 5-9 days.
Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
52.7  (8.64) 44.7  (9.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A (Test Lens), Nelfilcon A (Active Comparator)
Comments Ho:The test lens is non-inferior to the active comparator lens for overall quality of vision at 1-week follow-up. A non-inferiority margin of -5 units was used.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method linear mixed model
Comments Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and site and patient as random effects.
Method of Estimation Estimation Parameter least-square mean difference
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
0.58 to 14.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.55
Estimation Comments Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etafilcon A Toric / Nelfilcon A Toric
Hide Arm/Group Description etafilcon A toric contact lens worn daily during first period of a maximum of 9 days, nelfilcon A toric contact lens worn during second period of a maximum of 9 days
All-Cause Mortality
Etafilcon A Toric / Nelfilcon A Toric
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etafilcon A Toric / Nelfilcon A Toric
Affected / at Risk (%)
Total   0/69 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etafilcon A Toric / Nelfilcon A Toric
Affected / at Risk (%)
Total   0/69 (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.
Publications require agreement and written approval from Sponsor.
Results Point of Contact
Name/Title: Ross Franklin
Organization: Johnson & Johnson Vision Care
Phone: 1-904-443-1379
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01055132     History of Changes
Other Study ID Numbers: CR-1476AG
First Submitted: January 22, 2010
First Posted: January 25, 2010
Results First Submitted: November 3, 2011
Results First Posted: February 7, 2013
Last Update Posted: June 19, 2018