Astigmatism
Conditions
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.
Interventions
contact lens to correct astigmatism
DEVICENelfilcon A toric contact lens
contact lens to correct astigmatism
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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). |
Countries
United States
Participant flow
Pre-assignment details
One subject failed screening, and did not enter group assignment
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who completed the study. | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (5-9 Days) | unsatisfactory lens fitting performance | 1 | 0 |
| Period 2 (5-9 Days) | Unsatisfactory lens fitting performance | 0 | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 5.27 |
| Region of Enrollment United States | 69 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 69 |
| serious Total, serious adverse events | 0 / 69 |
Outcome results
Primary
Binocular Visual Acuity on LogMAR Scale
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
Population: Analysis was conducted on subjects who successfully complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A Toric (Test Lens) | Binocular Visual Acuity on LogMAR Scale | -0.122 LogMAR | Standard Deviation 0.0718 |
| Nelfilcon A Toric (Active Comparator) | Binocular Visual Acuity on LogMAR Scale | -0.108 LogMAR | Standard Deviation 0.0766 |
Comparison: 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.95% CI: [-0.027, -0.003]linear mixed model
Primary
Monocular Visual Acuity on LogMAR Scale
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
Population: Analysis was conducted on subjects who successfully complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A Toric (Test Lens) | Monocular Visual Acuity on LogMAR Scale | -0.065 logMAR | Standard Deviation 0.0777 |
| Nelfilcon A Toric (Active Comparator) | Monocular Visual Acuity on LogMAR Scale | -0.038 logMAR | Standard Deviation 0.1057 |
Comparison: 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.95% CI: [-0.041, -0.0013]linear mixed model
Primary
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
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
Population: Analysis was conducted on subjects who successfully complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A Toric (Test Lens) | Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire | 56.4 units on a scale | Standard Deviation 9.12 |
| Nelfilcon A Toric (Active Comparator) | Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire | 44.0 units on a scale | Standard Deviation 9.34 |
Comparison: 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.95% CI: [4.05, 19.79]linear mixed model
Primary
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
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
Population: Analysis was conducted on subjects who successfully complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A Toric (Test Lens) | Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. | 52.7 units on a scale | Standard Deviation 8.64 |
| Nelfilcon A Toric (Active Comparator) | Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. | 44.7 units on a scale | Standard Deviation 9.41 |
Comparison: 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.95% CI: [0.58, 14.8]linear mixed model