Presbyopia
Conditions
Brief summary
Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.
Interventions
DEVICEetafilcon A (multi-focal)
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
DEVICEetafilcon A (sphere)
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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 between 40 and 70 years of age. 4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye. 5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye. 6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye. 7. The subject best corrected visual acuity of 20/20 -3 or better in each eye. 8. Subject must own a wearable pair of spectacles. 9. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration) 10. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the Presbyopic Symptoms Questionnaire.
Exclusion criteria
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. Any ocular abnormality that may interfere 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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) 7. Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. 8. Any ocular infection or inflammation. 9. History of herpetic keratitis. 10. Any corneal distortion or irregular cornea. 11. History of binocular vision abnormality or strabismus. 12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV). 13. Current history of diabetes. 14. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. | 15 minutes post Contact Lens Insertion | CLUE Overall Lens Handling 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). |
Countries
United States
Participant flow
Pre-assignment details
This study enrolled a total of 195 subjects. Of those enrolled, 4 subjects did not meet the eligibility criteria, and 191 subjects were dispensed study lenses. Of those dispensed, subjects 189 completed the study and 2 subjects were discontinued. Subjects were stratified as either Hyperops or Myopes based on their sphere power.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A(Multi-focal)/ Etafilcon A(Sphere) Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens. | 94 |
| Etafilcon A(Sphere) / Etafilcon A(Multi-focal) Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens. | 97 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (15 Minutes) | Lost to Follow-up | 0 | 1 |
| Period 1 (15 Minutes) | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Etafilcon A(Sphere) / Etafilcon A(Multi-focal) | Total | Etafilcon A(Multi-focal)/ Etafilcon A(Sphere) |
|---|---|---|---|
| Age, Continuous Hyperopes, N=38, N=33, N=71 | 57.3 years STANDARD_DEVIATION 6.45 | 56.2 years STANDARD_DEVIATION 7.06 | 55.2 years STANDARD_DEVIATION 7.49 |
| Age, Continuous Myopes, N=56, N=64, N=120 | 51.1 years STANDARD_DEVIATION 7.24 | 51.0 years STANDARD_DEVIATION 7.12 | 50.8 years STANDARD_DEVIATION 7.03 |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black of African American | 8 participants | 12 participants | 4 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 87 participants | 176 participants | 89 participants |
| Region of Enrollment United States | 97 participants | 191 participants | 94 participants |
| Sex: Female, Male Female | 83 Participants | 153 Participants | 70 Participants |
| Sex: Female, Male Male | 14 Participants | 38 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 191 | 0 / 191 |
| serious Total, serious adverse events | 0 / 191 | 0 / 191 |
Outcome results
Primary
Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
CLUE Overall Lens Handling 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: 15 minutes post Contact Lens Insertion
Population: The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A(Multi-focal) | Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. | Hyperopes, N=69, N=69 | 53.44 units on a scale | Standard Deviation 25.482 |
| Etafilcon A(Multi-focal) | Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. | Myopes, N=115, N=115 | 61.70 units on a scale | Standard Deviation 24.594 |
| Etafilcon A (Sphere) | Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. | Hyperopes, N=69, N=69 | 55.81 units on a scale | Standard Deviation 26.432 |
| Etafilcon A (Sphere) | Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. | Myopes, N=115, N=115 | 60.23 units on a scale | Standard Deviation 23.369 |