Visual Acuity
Conditions
Brief summary
This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.
Interventions
COMBINATION_PRODUCTetafilcon A with ketotifen
Etafilcon A with ketotifen
DEVICE1-Day ACUVUE
1-Day ACUVUE
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study 1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Between 18 and 39 (inclusive) years of age at the time of baseline visit. 4. The subject must be a habitual lens wearer for a least 6 days/week and for a minimum of 8 hours per day over the last month. 5. The subject's contact lens correction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye. 6. The subject's refractive cylinder must be 1.00 D or less in each eye. 7. Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye (Snellen Visual Acuity).
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating. 2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. 3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. 4. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion. 5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear, history of strabismus, or current monovision, multi-focal, or toric contact lens correction. 6. Any current use of rewetting drops or ocular medication. 7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 8. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Biomicroscopy Scale. 9. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear. 10. Any known hypersensitivity or allergic reaction to ketotifen. 11. Participation in any eye drop, contact lens or lens care product clinical trial within 14 days prior to study enrollment. 12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) | Baseline (Visit 1) and 1-week follow up (Visit 2) | Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit. |
| Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) | Baseline (Visit 1) and 1-week follow up (Visit 2) | Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Eyes With Clinically Significant Slit Lamp Findings | Up to 1-Week Follow-up | Slit lamp findings were assessed using a biomicroscope for each subject eye at all scheduled and unscheduled visits. Clinical significant slit lamp findings are defined as Grade 3 or Grade 4. (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate and Grade 4= Severe). The data was dichotomized as 1=Grade 3 or Grade 4 and 0, otherwise. The number of eyes with clinically significant slit lamp findings for each lens type was reported. |
| The Number of Eyes With Unacceptable Lens Fitting | Up to 1-Week Follow-up | Lens fit was assessed for each subject and eye using a biomicroscope. Unacceptable lens fit was assessed at all scheduled and unscheduled visits. A subject was deemed to have an unacceptable lens fitting if they met any of the following criteria: (1) Limbal exposure at primary gaze with extreme eye movement, (2) edge lift, (3) excessive movement in primary up gaze, (4) insufficient movement in all three of the following conditions: primary gaze, up gaze and push up test. The number of eyes with unacceptable lens fitting was reported for each lens type. |
Countries
United States
Participant flow
Pre-assignment details
A total of 143 subjects were enrolled into this study. Of those enrolled, 141 were dispensed a study lens and 2 subjects were enrolled but not dispensed. Of the dispensed subjects 140 completed the study and 1 discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A With Ketotifen Subjects that were randomized to the etafilcon A with ketotifen contact lens throughout the entire duration of the study. | 94 |
| Etafilcon A Subjects that were randomized to the etafilcon A contact lens throughout the entire duration of the study. | 47 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Etafilcon A With Ketotifen | Etafilcon A | Total |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 4.98 | 29.6 years STANDARD_DEVIATION 4.56 | 30.1 years STANDARD_DEVIATION 4.84 |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 83 Participants | 43 Participants | 126 Participants |
| Region of Enrollment United States | 94 participants | 47 participants | 141 participants |
| Sex: Female, Male Female | 59 Participants | 31 Participants | 90 Participants |
| Sex: Female, Male Male | 35 Participants | 16 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 47 |
| other Total, other adverse events | 0 / 94 | 0 / 47 |
| serious Total, serious adverse events | 0 / 94 | 0 / 47 |
Outcome results
Primary
Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population)
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.
Time frame: Baseline (Visit 1) and 1-week follow up (Visit 2)
Population: Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A With Ketotifen | Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) | Visit 1 (Baseline) | -0.109 logMAR | Standard Deviation 0.074 |
| Etafilcon A With Ketotifen | Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) | Visit 2 (1-week follow up) | -0.115 logMAR | Standard Deviation 0.0717 |
| Etafilcon A | Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) | Visit 1 (Baseline) | -0.110 logMAR | Standard Deviation 0.0806 |
| Etafilcon A | Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) | Visit 2 (1-week follow up) | -0.117 logMAR | Standard Deviation 0.0815 |
95% CI: [-0.022, 0.024]Linear Mixed Model
Primary
Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population)
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.
Time frame: Baseline (Visit 1) and 1-week follow up (Visit 2)
Population: Per-protocol (PP) population which consists of all subjects who completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A With Ketotifen | Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) | Visit 1 (Baseline) | -0.111 logMAR | Standard Deviation 0.0702 |
| Etafilcon A With Ketotifen | Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) | Visit 2 (1-week follow up) | -0.115 logMAR | Standard Deviation 0.0717 |
| Etafilcon A | Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) | Visit 1 (Baseline) | -0.109 logMAR | Standard Deviation 0.0809 |
| Etafilcon A | Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) | Visit 2 (1-week follow up) | -0.118 logMAR | Standard Deviation 0.0814 |
95% CI: [-0.021, 0.025]Linear Mixed Model
Secondary
The Number of Eyes With Clinically Significant Slit Lamp Findings
Slit lamp findings were assessed using a biomicroscope for each subject eye at all scheduled and unscheduled visits. Clinical significant slit lamp findings are defined as Grade 3 or Grade 4. (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate and Grade 4= Severe). The data was dichotomized as 1=Grade 3 or Grade 4 and 0, otherwise. The number of eyes with clinically significant slit lamp findings for each lens type was reported.
Time frame: Up to 1-Week Follow-up
Population: Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article. MITT is identical to safety population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etafilcon A With Ketotifen | The Number of Eyes With Clinically Significant Slit Lamp Findings | 0 Number of Eyes |
| Etafilcon A | The Number of Eyes With Clinically Significant Slit Lamp Findings | 0 Number of Eyes |
Secondary
The Number of Eyes With Unacceptable Lens Fitting
Lens fit was assessed for each subject and eye using a biomicroscope. Unacceptable lens fit was assessed at all scheduled and unscheduled visits. A subject was deemed to have an unacceptable lens fitting if they met any of the following criteria: (1) Limbal exposure at primary gaze with extreme eye movement, (2) edge lift, (3) excessive movement in primary up gaze, (4) insufficient movement in all three of the following conditions: primary gaze, up gaze and push up test. The number of eyes with unacceptable lens fitting was reported for each lens type.
Time frame: Up to 1-Week Follow-up
Population: Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article. MITT is identical to safety population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etafilcon A With Ketotifen | The Number of Eyes With Unacceptable Lens Fitting | 0 eyes |
| Etafilcon A | The Number of Eyes With Unacceptable Lens Fitting | 1 eyes |