Lapsed Contact Lens Wear
Conditions
Brief summary
This study is an open-label, multi-site study. The total number of subjects was 200. The duration of this study was approximately four weeks. The primary objective was to assess what percentage of lapsed contact wearers, who have discontinued use of their contact lenses for greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly replacement daily wear lenses (spherical and toric designs).
Interventions
DEVICEsenofilcon A
DEVICEsenofilcon A for Astigmatism
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 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 interested in wearing contact lenses. 4. The subject must be at least 18 years old or less than 40 years of age at the time of consent. 5. The subject's vertexed spherical cylindrical refraction must result in a contact lens prescription for each eye that is available in the investigator's choice of study contact lens material(s). 6. The subject must have best corrected visual acuity of 20/30 or better in each eye. 7. The subject must require visual correction in both eyes. 8. The subject must be a lapsed wearer (defined as, any non-contact lens wearer requiring optical correction who has been previously fitted in and has previously purchased contact lenses but has since discontinued contact lens wear for any reason more than 6 months prior to the time of consent). 9. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
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. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. 5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.) 6. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, 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 tha may contraindicate contact lens wear. 7. Any ocular infection. 8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 9. Participation in any contact lens or lens care trial within one year prior to study enrollment. 10. History of binocular vision abnormality or strabismus. 11. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g., HIV), by self report. 12. Employee of the investigational clinic (i.e., Investigator, Coordinator, or Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Successfully Re-fitted Subjects | 4 weeks | Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology. |
Countries
United States
Participant flow
Pre-assignment details
A total of 199 subjects were enrolled in the study; 7 subjects were enrolled but not randomized. 18 subjects were discontinued and 174 subjects completed the study. Of those 174 completed subjects, 5 subjects had major protocol deviations; 169 subjects were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Control (Senfilcon A) Consists of subjects that were dispensed at least one Control lens. | 102 |
| Test (Senofilcon A) Consists of subjects that were dispensed at least one Test lens. | 90 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lens Discomfort | 1 | 1 |
| Overall Study | Lens Handling Difficulties | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 6 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Unsatisfactory Visual Response | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Control (Senfilcon A) | Test (Senofilcon A) | Total |
|---|---|---|---|
| Age, Continuous | 29.80 years STANDARD_DEVIATION 6.356 | 29.22 years STANDARD_DEVIATION 5.715 | 29.57 years STANDARD_DEVIATION 6.096 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Black or African American | 20 participants | 22 participants | 42 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 78 participants | 65 participants | 143 participants |
| Region of Enrollment United States | 102 participants | 90 participants | 192 participants |
| Sex: Female, Male Female | 69 Participants | 62 Participants | 131 Participants |
| Sex: Female, Male Male | 33 Participants | 28 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 102 | 0 / 90 |
| serious Total, serious adverse events | 0 / 102 | 0 / 90 |
Outcome results
Primary
Proportion of Successfully Re-fitted Subjects
Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.
Time frame: 4 weeks
Population: The analysis population includes all subjects who have completed all study visits without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (Senofilcon A) | Proportion of Successfully Re-fitted Subjects | 100 percentage of Subjects |
| Test (Senofilcon A) | Proportion of Successfully Re-fitted Subjects | 95.52 percentage of Subjects |