Vision Correction
Conditions
Brief summary
The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.
Interventions
DEVICEMultifocal Test Contact lens
Used in a daily wear modality
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 -1.00 to +2.00 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. 7. The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion criteria
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any ocular or systemic allergies that contraindicate contact lens wear. 3. Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates 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, PRK, LASIK, etc.). 7. 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. 8. History of herpetic keratitis. 9. Any ocular infection or inflammation. 10. Any corneal distortion or irregular cornea. 11. History of binocular vision abnormality or strabismus. 12. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV). 13. History of diabetes. 14. Current or previous history of being prescribed a correction for distance vision. 15. Current or previous history of contact lens wear. 16. 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 |
|---|---|---|
| Proportion of Successful Contact Lens Wearers | 2 months post wear | Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, Overall Quality of Vision and Overall Comfort. Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded Excellent, Very Good or Good then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers. |
Countries
United Kingdom, United States
Participant flow
Pre-assignment details
A total of 113 enrolled into this study. Of the enrolled, 5 subjects did not meet the eligibility criteria and 108 subjects were dispensed the study lens. Of the dispensed subjects 79 completed the study while 29 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects in that were dispensed the study lens. | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lens Discomfort | 3 |
| Overall Study | Lens handling difficulities | 5 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | No longer meet eligibility criteria | 1 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Unsatisfactory Visual Response | 5 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 6.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United Kingdom | 62 participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 108 |
| serious Total, serious adverse events | 0 / 108 |
Outcome results
Primary
Proportion of Successful Contact Lens Wearers
Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, Overall Quality of Vision and Overall Comfort. Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded Excellent, Very Good or Good then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers.
Time frame: 2 months post wear
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etafilcon -PVP (Multi-focal) | Proportion of Successful Contact Lens Wearers | 0.71 Proportion of Subjects |