Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Sponsor
Johnson & Johnson Vision Care, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01055132
Collaborator
(none)
70
Enrollment
6
Locations
2
Arms
1
Duration (Months)
11.7
Patients Per Site
11.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Etafilcon A toric contact lens
  • Device: Nelfilcon A toric contact lens
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Other: Etafilcon A toric contact lens/Nelfilcon A toric

Etafilcon A toric contact lens first, then nelfilcon A toric second

Device: Etafilcon A toric contact lens
contact lens to correct astigmatism

Device: Nelfilcon A toric contact lens
contact lens to correct astigmatism

Other: Nelfilcon A toric/ Etafilcon A toric

Nelfilcon A toric contact lens first, then etafilcon A toric toric second

Device: Etafilcon A toric contact lens
contact lens to correct astigmatism

Device: Nelfilcon A toric contact lens
contact lens to correct astigmatism

Outcome Measures

Primary Outcome Measures

  1. Monocular Visual Acuity on LogMAR Scale [After 5 to 9 days of lens wear]

    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.

  2. Binocular Visual Acuity on LogMAR Scale [After 5 to 9 days of lens wear]

    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.

  3. Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire [After 5 to 9 days of lens wear]

    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).

  4. Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. [After 5 to 9 days of lens wear]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The subject must be between 18 and 40 years old.

  • The subject must have normal eyes.

  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

  • The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

  • The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.

  • The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.

  • The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.

  • The subject must be an adapted wearer of soft toric contact lenses in both eyes.

  • The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.

  • Subjects must already possess a wearable pair of spectacles.

Exclusion Criteria:
  • Ocular or systemic allergies or disease that may interfere with contact lens wear.

  • Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.

  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.

  • Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.

  • Any ocular infection.

  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

  • Pregnancy or lactation

  • Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

  • Diabetes

  • Strabismus

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Los AngelesCaliforniaUnited States90049
2JacksonvilleFloridaUnited States32205
3JacksonvilleFloridaUnited States32256
4MariettaGeorgiaUnited States30060
5New YorkNew YorkUnited States10001
6WarwickRhode IslandUnited States02886

Sponsors and Collaborators

  • Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01055132
Other Study ID Numbers:
  • CR-1476AG
First Posted:
Jan 25, 2010
Last Update Posted:
Jun 19, 2018
Last Verified:
May 1, 2015
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailOne subject failed screening, and did not enter group assignment
Arm/Group TitleEtafilcon A Toric Lens First/ Nelfilcon A Toric Lens SecondNelfilcon A Toric Lens First/Etafilcon A Toric Lens Second
Arm/Group DescriptionEtafilcon 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 daysNelfilcon 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)
STARTED3633
COMPLETED3533
NOT COMPLETED10
Period Title: Period 1 (5-9 Days)
STARTED3533
COMPLETED3532
NOT COMPLETED01

Baseline Characteristics

Arm/Group TitleAll Subjects
Arm/Group DescriptionAll subjects who completed the study.
Overall Participants69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
29.1
(5.27)
Sex: Female, Male (Count of Participants)
Female
45
65.2%
Male
24
34.8%
Region of Enrollment (participants) [Number]
United States
69
100%

Outcome Measures

1. Primary Outcome
TitleMonocular Visual Acuity on LogMAR Scale
DescriptionDistance (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 FrameAfter 5 to 9 days of lens wear

Outcome Measure Data

Analysis Population Description
Analysis was conducted on subjects who successfully complete the study.
Arm/Group TitleEtafilcon A Toric (Test Lens)Nelfilcon A Toric (Active Comparator)
Arm/Group DescriptionEtafilcon 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 daysAn existing, daily disposable toric contact lens; worn 5-9 days
Measure Participants6767
Mean (Standard Deviation) [logMAR]
-0.065
(0.0777)
-0.038
(0.1057)
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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterLeast-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 CommentsComparison 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
TitleBinocular Visual Acuity on LogMAR Scale
DescriptionDistance (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 FrameAfter 5 to 9 days of lens wear

Outcome Measure Data

Analysis Population Description
Analysis was conducted on subjects who successfully complete the study.
Arm/Group TitleEtafilcon A Toric (Test Lens)Nelfilcon A Toric Lens (Active Comparator)
Arm/Group DescriptionEtafilcon 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 daysAn existing, daily disposable toric contact lens; worn 5-9 days
Measure Participants6767
Mean (Standard Deviation) [LogMAR]
-0.122
(0.0718)
-0.108
(0.0766)
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 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterLeast-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 CommentsComparison 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
TitleSubject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
DescriptionThe 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 FrameAfter 5 to 9 days of lens wear

Outcome Measure Data

Analysis Population Description
Analysis was conducted on subjects who successfully complete the study.
Arm/Group TitleEtafilcon A (Test Lens)Nelfilcon A (Active Comparator)
Arm/Group DescriptionEtafilcon 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 daysAn existing, daily disposable toric contact lens; worn for 5-9 days
Measure Participants6767
Mean (Standard Deviation) [units on a scale]
56.4
(9.12)
44.0
(9.34)
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 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterLeast-square mean difference
Estimated Value11.9
Confidence Interval (2-Sided) 95%
4.05 to 19.79
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.93
Estimation CommentsComparison 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
TitleSubject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
DescriptionThe 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 FrameAfter 5 to 9 days of lens wear

Outcome Measure Data

Analysis Population Description
Analysis was conducted on subjects who successfully complete the study.
Arm/Group TitleEtafilcon A (Test Lens)Nelfilcon A (Active Comparator)
Arm/Group DescriptionEtafilcon 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 daysAn existing, daily disposable toric contact lens; worn for 5-9 days.
Measure Participants6767
Mean (Standard Deviation) [units on a scale]
52.7
(8.64)
44.7
(9.41)
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 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation Parameterleast-square mean difference
Estimated Value7.7
Confidence Interval (2-Sided) 95%
0.58 to 14.80
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.55
Estimation CommentsComparison 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.

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleEtafilcon A Toric / Nelfilcon A Toric
Arm/Group Descriptionetafilcon 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 (%)# Events
Total/ (NaN)
Serious Adverse Events
Etafilcon A Toric / Nelfilcon A Toric
Affected / at Risk (%)# Events
Total0/69 (0%)
Other (Not Including Serious) Adverse Events
Etafilcon A Toric / Nelfilcon A Toric
Affected / at Risk (%)# Events
Total0/69 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publications require agreement and written approval from Sponsor.

Results Point of Contact

Name/TitleRoss Franklin
OrganizationJohnson & Johnson Vision Care
Phone1-904-443-1379
EmailRFrankl1@its.jnj.com
Responsible Party:
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01055132
Other Study ID Numbers:
  • CR-1476AG
First Posted:
Jan 25, 2010
Last Update Posted:
Jun 19, 2018
Last Verified:
May 1, 2015