Presbyopia
Conditions
Brief summary
This study is a randomized, single-masked, crossover clinical trial. There are two study lenses. Each lens will be dispensed for 3 ± 1 days and then an optimization visit will occur. The final lens pair will be dispensed for 12 ± 2 days and the follow-up on the final lens pair will occur. The second study lenses will then be fit and the above sequence repeated.
Interventions
DEVICE1-Day Acuvue® Moist Brand Multifocal Contact Lens
CONTROL
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 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. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent. 4. Subjects must own a wearable pair of spectacles if required for their distance vision. 5. The subject must 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 or more duration). 6. The subject must either 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 (Appendix E). 7. The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D in each eye. 8. The subject's refractive cylinder must be ≤0.75 D in each eye. 9. The subject's ADD power must be in the range of +0.75 D to +2.50 D. 10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.
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 active or ongoing ocular or systemic allergies that may interfere with contact lens wear. 3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). 4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 5. A history of amblyopia, strabismus or binocular vision abnormality. 6. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines, oral/topical/inhaled anticholinergics, systemic/topical corticosteroids. 7. Use of any ocular medication, with the exception of rewetting drops. 8. History of herpetic keratitis. 9. History of irregular cornea. 10. History of pathological dry eye. 11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 13. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution, sodium fluorescein or non-preserved rewetting drop solutions. 14. Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear. 15. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions. 16. Any current ocular infection or inflammation. 17. Any current ocular abnormality that may interfere with contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | 2-Week Follow-up | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. |
| Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | 2-Week Follow-up | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. |
| Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | 2-Week Follow-up | The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision Scores | 2-Week Follow-up | Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. |
| Proportion of Subjects That Reported Ocular Symptoms | 2-Week Follow-up | Subject reported ocular symptoms were assessed using a questionnaire at the 2-week follow-up. Subjects were asked if they experienced any of the following symptoms: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other; using the scale of: None, Mild, Moderate and Severe. The proportion of subjects that reported symptoms (Mild, Moderate and Severe) was reported for each lens type. |
| Overall Comfort Scores | 2-Week Follow-up | Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. |
| Number of Grade 3 or Higher Slit Lamp Findings | 2-Week Follow-up | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings were assessed at the 2-Week Follow-up. SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The number of eyes with SLF with grade 3 or higher by lens was reported. |
Countries
United States
Participant flow
Pre-assignment details
A total of 46 subjects were enrolled in this study. Of those enrolled, 44 (95.7%) subjects randomized and dispensed at least 1 study lens while, 2 (4.3%) subjects failed to meet all eligibility criteria. Of those dispensed, 43 (93.5%) subjects completed the study while, 1 (2.2%) subject was discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Subjects that wore either Test or Control lens in either first or second period of the study. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 6.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Region of Enrollment United States | 44 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Time frame: 2-Week Follow-up
Population: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | Standard High Contrast Bright: Distance | -0.12 logMAR | Standard Deviation 0.073 |
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | Standard High Contrast Bright: Intermediate | -0.06 logMAR | Standard Deviation 0.07 |
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | Standard High Contrast Bright: Near | 0.07 logMAR | Standard Deviation 0.097 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | Standard High Contrast Bright: Distance | -0.12 logMAR | Standard Deviation 0.067 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | Standard High Contrast Bright: Intermediate | -0.06 logMAR | Standard Deviation 0.072 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright | Standard High Contrast Bright: Near | 0.08 logMAR | Standard Deviation 0.106 |
Primary
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Time frame: 2-Week Follow-up
Population: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | Standard High Contrast Dim with Goggles: Distance | 0.14 logMAR | Standard Deviation 0.109 |
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | Standard High Contrast Dim with Goggles: Intermediate | 0.02 logMAR | Standard Deviation 0.095 |
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | Standard High Contrast Dim with Goggles: Near | 0.18 logMAR | Standard Deviation 0.098 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | Standard High Contrast Dim with Goggles: Distance | 0.13 logMAR | Standard Deviation 0.085 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | Standard High Contrast Dim with Goggles: Intermediate | 0.00 logMAR | Standard Deviation 0.091 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles | Standard High Contrast Dim with Goggles: Near | 0.16 logMAR | Standard Deviation 0.101 |
Primary
Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Time frame: 2-Week Follow-up
Population: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | Standard Low Contrast Bright: Distance | 0.08 logMAR | Standard Deviation 0.093 |
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | Standard Low Contrast Bright: Intermediate | 0.12 logMAR | Standard Deviation 0.075 |
| Test (Senofilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | Standard Low Contrast Bright: Near | 0.25 logMAR | Standard Deviation 0.113 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | Standard Low Contrast Bright: Distance | 0.07 logMAR | Standard Deviation 0.075 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | Standard Low Contrast Bright: Intermediate | 0.10 logMAR | Standard Deviation 0.094 |
| Control (Etafilcon A) | Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright | Standard Low Contrast Bright: Near | 0.27 logMAR | Standard Deviation 0.119 |
Secondary
Number of Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings were assessed at the 2-Week Follow-up. SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The number of eyes with SLF with grade 3 or higher by lens was reported.
Time frame: 2-Week Follow-up
Population: Analysis population consisted of all subjects who were dispensed at least 1 study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test (Senofilcon A) | Number of Grade 3 or Higher Slit Lamp Findings | 0 number of eyes |
| Control (Etafilcon A) | Number of Grade 3 or Higher Slit Lamp Findings | 0 number of eyes |
Secondary
Overall Comfort Scores
Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 2-Week Follow-up
Population: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Senofilcon A) | Overall Comfort Scores | 64.51 CLUE points | Standard Deviation 26.63 |
| Control (Etafilcon A) | Overall Comfort Scores | 62.71 CLUE points | Standard Deviation 24.006 |
Secondary
Overall Vision Scores
Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 2-Week Follow-up
Population: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Senofilcon A) | Overall Vision Scores | 52.24 CLUE points | Standard Deviation 22.035 |
| Control (Etafilcon A) | Overall Vision Scores | 50.24 CLUE points | Standard Deviation 23.282 |
Secondary
Proportion of Subjects That Reported Ocular Symptoms
Subject reported ocular symptoms were assessed using a questionnaire at the 2-week follow-up. Subjects were asked if they experienced any of the following symptoms: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other; using the scale of: None, Mild, Moderate and Severe. The proportion of subjects that reported symptoms (Mild, Moderate and Severe) was reported for each lens type.
Time frame: 2-Week Follow-up
Population: Analysis population consisted of all subjects who were dispensed at least 1 study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test (Senofilcon A) | Proportion of Subjects That Reported Ocular Symptoms | 0.837 proportion |
| Control (Etafilcon A) | Proportion of Subjects That Reported Ocular Symptoms | 0.813 proportion |