Vision Correction
Conditions
Brief summary
The purpose of this clinical trial is to compare the overall lens fit acceptance of two different soft contact lenses in an Asian population.
Interventions
DEVICEetafilcon A
Each study subject will be exposed to both test lenses following a washout period of five minutes between test periods.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 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 the clinical protocol. 3. The subject must be an Asian female (self-reported). 4. The subject must be at least 18 years old and less than 41 years old. 5. The subject must meet two of the four East Asian anatomical categories (Appendix D) and have a prominent epicanthic fold to be classified East Asian ethnicity. For the purpose of this protocol, East Asian ethnicities may include: China, Japan, Korea, Taiwan, Vietnam, Hong Kong, Malaysia, and Singapore but are not inclusive of these regions. 6. The subject must be a habitual soft contact lens wearer. Habitual is defined as: at least one month of daily wear where the lenses are worn a minimum of six (6) hours per day and a minimum of three (3) days per week prior to enrollment in the study. 7. The subject's optimal non-vertexed spherical equivalent distance correction (based on their optimal sphero-cylinder refraction) must be between +2.00 D and -12.00 D. 8. Any cylinder power must be less than or equal to -1.00 D confirmed by refraction. 9. The subject must possess a functional/usable pair of spectacles and wear them to the visit (only if applicable-to the investigator's discretion). 10. The subject's best correctable visual acuity is 20/40 or better (OD and OS) at the baseline visit.
Exclusion criteria
1. Ocular or systemic allergies which might interfere with contact lens wear. 2. Ocular or systemic disease which might interfere with contact lens wear. 3. Any known hypersensitivity or allergic reaction to contact lenses or contact lens solutions. 4. Use of any ocular or topical medication. 5. Use of any systemic (oral) medication that is taken for an ocular condition which might interfere with contact lens wear. 6. Use of any systemic (oral) medication that is taken for a systemic condition which might interfere with the contact lens wear (this determination will be at the discretion of the investigator). 7. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormalities of the cornea and/or conjunctiva which would contraindicate contact lens wear. 8. Rigid gas permeable or hybrid design (rigid gas permeable center and a soft lens skirt) contact lens wear within the past 30 days. 9. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. 10. Any previous or planned (during duration of the study), ocular or intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), peripheral iridotomy, etc.) 11. Pregnancy or lactation. 12. Diabetes. 13. Infectious disease. 14. Habitual contact lens type is multifocal, monovision or worn as extended wear. 15. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. 16. Suspicion of or recent history od alcohol or substance abuse. 17. History of serious mental illness. 18. History of seizures. 19. Employee or family member of the investigational clinic (e.g. Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Lens Fit Acceptance | 15 mins post insertion | The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp. |
| Cosmetic Lens Fit Acceptance | 15 mins post insertion | The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp. |
| Lens Does Not Exhibit Hula Hoop Effect | 15 mins post insertion | The number of subjects that did not exhibit a hula hoop effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp. |
Countries
Canada, United States
Participant flow
Pre-assignment details
206 subjects were enrolled in this study. 16 subjects did not meet the eligibility criteria. 190 subjects were dispensed lenses and, 177 subjects completed all study visits without a major protocol deviation. 13 subjects were recorded as having protocol violations. No subjects were discontinued during this study.
Participants by arm
| Arm | Count |
|---|---|
| Overall All subjects that were dispensed a test article during the study. | 190 |
| Total | 190 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 24.75 years STANDARD_DEVIATION 4.416 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 190 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Canada | 29 participants |
| Region of Enrollment United States | 161 participants |
| Sex: Female, Male Female | 190 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 95 | 0 / 95 |
| serious Total, serious adverse events | 0 / 95 | 0 / 95 |
Outcome results
Primary
Cosmetic Lens Fit Acceptance
The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp.
Time frame: 15 mins post insertion
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test 1 | Cosmetic Lens Fit Acceptance | 349 Eyes |
| Test 2 | Cosmetic Lens Fit Acceptance | 349 Eyes |
Primary
Lens Does Not Exhibit Hula Hoop Effect
The number of subjects that did not exhibit a hula hoop effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp.
Time frame: 15 mins post insertion
Population: The analysis population consists of subjects that completed all study visits, without a major protocol deviation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test 1 | Lens Does Not Exhibit Hula Hoop Effect | 176 Subject |
| Test 2 | Lens Does Not Exhibit Hula Hoop Effect | 176 Subject |
Primary
Mechanical Lens Fit Acceptance
The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.
Time frame: 15 mins post insertion
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test 1 | Mechanical Lens Fit Acceptance | 345 Eyes |
| Test 2 | Mechanical Lens Fit Acceptance | 337 Eyes |