Presbyopia
Conditions
Brief summary
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.
Interventions
DEVICElotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
DEVICEetafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Between 40 and 70 years of age. 4. Subjects must own a wearable pair of spectacles, if required for their distance vision. 5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration) 6. Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire\* 7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye. 8. Refractive cylinder ≤ -0.75 D in each eye. 9. ADD power in the range +0.75 D to +2.50 D in each eye. 10. Best corrected visual acuity of 20/20-3 or better in each eye.
Exclusion criteria
1. Currently pregnant or lactating (subjects who became pregnant during the study were discontinued). 2. Any ocular or systemic allergies that may have contraindicated contact lens wear. 3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear. 4. Any ocular abnormality that may have interfered with contact lens wear. 5. Use of any ocular medication, with the exception of rewetting drops. 6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 7. History of herpetic keratitis. 8. History of binocular vision abnormality or strabismus. 9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV). 10. History of diabetes. 11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. 13. Any ocular infection or inflammation. 14. Any corneal distortion or irregular cornea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire | 8 -12 days post wear | CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. 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). |
| Distance Binocular Visual Acuity (LogMAR) | 8- 12 Days post wear | Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast. |
| Intermediate Binocular Visual Acuity (LogMAR) | 8-12 days post wear | Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast. |
| Near Binocular Visual Acuity (LogMAR) | 8-12 days post wear | Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast. |
| Corneal Staining | 8 - 12 Days post wear | Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. |
| Bulbar Conjunctival Injection | 8- 12 Days post wear | The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. |
| Limbal Conjunctival Injection | 8- 12 Days post wear | The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. |
| Contact Lens Fitting | 8- 12 Days post wear | Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported. |
Countries
United States
Participant flow
Pre-assignment details
This study enrolled a total of 371 subjects. Of those enrolled subjects 49 did not meet the eligibility criteria and 322 subjects were dispensed a study lens. Of the dispensed subjects 297 completed the study and 25 were discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A / Lotrafilcon B Subjects that were randomized to this sequence and were dispensed a study lens. | 163 |
| Lotrafilcon B / Etafilcon A Subjects that were randomized to this sequence and were dispensed a study lens. | 159 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 0 |
| Period 1 | Lost to Follow-up | 0 | 1 |
| Period 1 | Protocol Violation | 2 | 4 |
| Period 1 | Test Article No Longer Available | 1 | 5 |
| Period 1 | Unsatisfactory Visual Response | 0 | 1 |
| Period 1 | Withdrawal by Subject | 0 | 4 |
| Period 2 | Adverse Event | 0 | 1 |
| Period 2 | Lens Discomfort | 1 | 1 |
| Period 2 | Lost to Follow-up | 1 | 0 |
| Period 2 | Protocol Violation | 1 | 0 |
| Period 2 | Test Article No Longer Available | 0 | 1 |
Baseline characteristics
| Characteristic | Etafilcon A / Lotrafilcon B | Lotrafilcon B / Etafilcon A | Total |
|---|---|---|---|
| Age, Continuous Hyperopes, N=59, N=53, N=112 | 52.3 years STANDARD_DEVIATION 6.59 | 51.9 years STANDARD_DEVIATION 7.04 | 52.1 years STANDARD_DEVIATION 6.78 |
| Age, Continuous Myopes, N=104, N=106, N=210 | 49.3 years STANDARD_DEVIATION 6.1 | 49.5 years STANDARD_DEVIATION 5.77 | 49.4 years STANDARD_DEVIATION 5.92 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Black or African American | 15 participants | 10 participants | 25 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 147 participants | 144 participants | 291 participants |
| Region of Enrollment United States | 163 participants | 159 participants | 322 participants |
| Sex: Female, Male Female | 128 Participants | 120 Participants | 248 Participants |
| Sex: Female, Male Male | 35 Participants | 39 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 307 | 0 / 318 |
| serious Total, serious adverse events | 0 / 307 | 0 / 318 |
Outcome results
Primary
Bulbar Conjunctival Injection
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time frame: 8- 12 Days post wear
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Bulbar Conjunctival Injection | Hyperopes, N=188, N=188 | 0.0 Percentage of Subject Eyes |
| Etafilcon A | Bulbar Conjunctival Injection | Myopes, N=362 , N=362 | 0.0 Percentage of Subject Eyes |
| Lotrafilcon B | Bulbar Conjunctival Injection | Hyperopes, N=188, N=188 | 0.0 Percentage of Subject Eyes |
| Lotrafilcon B | Bulbar Conjunctival Injection | Myopes, N=362 , N=362 | 0.0 Percentage of Subject Eyes |
Primary
Contact Lens Fitting
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
Time frame: 8- 12 Days post wear
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Contact Lens Fitting | Hyperopes, N=188, N=188 | 100 Percentage of Subject Eyes |
| Etafilcon A | Contact Lens Fitting | Myopes, N=362, N=362 | 99.5 Percentage of Subject Eyes |
| Lotrafilcon B | Contact Lens Fitting | Hyperopes, N=188, N=188 | 100 Percentage of Subject Eyes |
| Lotrafilcon B | Contact Lens Fitting | Myopes, N=362, N=362 | 100 Percentage of Subject Eyes |
Primary
Corneal Staining
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time frame: 8 - 12 Days post wear
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Corneal Staining | Myopes, N=362, N=362 | 0.0 percentage of Subject Eyes |
| Etafilcon A | Corneal Staining | Hyperopes, N=188, N=188 | 0.0 percentage of Subject Eyes |
| Lotrafilcon B | Corneal Staining | Hyperopes, N=188, N=188 | 0.0 percentage of Subject Eyes |
| Lotrafilcon B | Corneal Staining | Myopes, N=362, N=362 | 0.0 percentage of Subject Eyes |
Primary
Distance Binocular Visual Acuity (LogMAR)
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Time frame: 8- 12 Days post wear
Population: The analysis population consists of subjects that have completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Distance Binocular Visual Acuity (LogMAR) | Hyperopes, N=94, N=94 | -0.069 LogMAR | Standard Deviation 0.0908 |
| Etafilcon A | Distance Binocular Visual Acuity (LogMAR) | Myopes, N=180, N=181 | -0.100 LogMAR | Standard Deviation 0.0991 |
| Lotrafilcon B | Distance Binocular Visual Acuity (LogMAR) | Hyperopes, N=94, N=94 | -0.066 LogMAR | Standard Deviation 0.0982 |
| Lotrafilcon B | Distance Binocular Visual Acuity (LogMAR) | Myopes, N=180, N=181 | -0.093 LogMAR | Standard Deviation 0.0981 |
Primary
Intermediate Binocular Visual Acuity (LogMAR)
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time frame: 8-12 days post wear
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Intermediate Binocular Visual Acuity (LogMAR) | Hyperopes, N=94, N=94 | -0.061 LogMAR | Standard Deviation 0.0829 |
| Etafilcon A | Intermediate Binocular Visual Acuity (LogMAR) | Myopes, N=180, N=181 | -0.081 LogMAR | Standard Deviation 0.0803 |
| Lotrafilcon B | Intermediate Binocular Visual Acuity (LogMAR) | Hyperopes, N=94, N=94 | -0.050 LogMAR | Standard Deviation 0.0897 |
| Lotrafilcon B | Intermediate Binocular Visual Acuity (LogMAR) | Myopes, N=180, N=181 | -0.063 LogMAR | Standard Deviation 0.0894 |
Primary
Limbal Conjunctival Injection
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time frame: 8- 12 Days post wear
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Limbal Conjunctival Injection | Hyperopes, N=188, N=188 | 0.0 Percentage of Subject Eyes |
| Etafilcon A | Limbal Conjunctival Injection | Myopes, N=362, N=362 | 0.0 Percentage of Subject Eyes |
| Lotrafilcon B | Limbal Conjunctival Injection | Hyperopes, N=188, N=188 | 0.0 Percentage of Subject Eyes |
| Lotrafilcon B | Limbal Conjunctival Injection | Myopes, N=362, N=362 | 0.0 Percentage of Subject Eyes |
Primary
Near Binocular Visual Acuity (LogMAR)
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time frame: 8-12 days post wear
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Near Binocular Visual Acuity (LogMAR) | Hyperopes, N=94, N=94 | 0.050 LogMAR | Standard Deviation 0.097 |
| Etafilcon A | Near Binocular Visual Acuity (LogMAR) | Myopes, N=180, N=181 | 0.034 LogMAR | Standard Deviation 0.1039 |
| Lotrafilcon B | Near Binocular Visual Acuity (LogMAR) | Hyperopes, N=94, N=94 | 0.074 LogMAR | Standard Deviation 0.1035 |
| Lotrafilcon B | Near Binocular Visual Acuity (LogMAR) | Myopes, N=180, N=181 | 0.049 LogMAR | Standard Deviation 0.1176 |
Primary
Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. 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: 8 -12 days post wear
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire | Hyperopes, N=94, N=94 | 51.15 units on a scale | Standard Deviation 21.647 |
| Etafilcon A | Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire | Myopes, N=181, N=181 | 53.55 units on a scale | Standard Deviation 18.644 |
| Lotrafilcon B | Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire | Hyperopes, N=94, N=94 | 54.28 units on a scale | Standard Deviation 20.749 |
| Lotrafilcon B | Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire | Myopes, N=181, N=181 | 51.84 units on a scale | Standard Deviation 19.319 |