Refractive Error
Conditions
Brief summary
Subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to four hours at each of the visits in order to take measurements on binocular functional visual performance.
Interventions
DEVICEHioxifilcon A Test
contact lens made with hioxifilcon A material
DEVICEHioxifilcon A With Cosmetic Ring Control
contact lens made with hioxifilcon A material with a cosmetic ring on the lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 42 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 35 and 42 years of age (inclusive). 4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -6.00 Diopters (D) to +4.00 D in each eye. 5. The subject's refractive cylinder must be ≤ 0.75 D in each eye. 6. The subject must have best corrected visual acuity of 20/30 or better in each eye. 7. The subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 6 hours of Daily Wear (DW) for a minimum of 1 month prior to the study). 8. 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 infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self-report. 4. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. 5. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 6. Any ocular infection. 7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) 8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 9. Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear. 10. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 11. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets. | 15 minutes post lens fit | Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets. | 15 Minutes post lens fitting | Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 2.5 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets. |
| The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets. | 15 Minutes post lens fitting | Time Controlled Visual Acuity (TCVA) was assessed at 67 cm using 50 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 24 subjects were enrolled into this study. Of the enrolled subjects 23 were dispensed a study lens while 1 subject failed to meet all eligibility criteria. Of the dispensed subjects, all 23 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed a study lens. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 38.0 Years STANDARD_DEVIATION 2.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 2 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United Kingdom | 23 Participants |
| Sex: Female, Male Female | 15 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 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.
Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.
Time frame: 15 minutes post lens fit
Population: All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hioxifilcon A (Test) | The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets. | -0.03 -10 x logMAR | Standard Deviation 0.754 |
| Hioxifilcon A (Control) | The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets. | 0.33 -10 x logMAR | Standard Deviation 0.656 |
Secondary
The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.
Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 2.5 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.
Time frame: 15 Minutes post lens fitting
Population: All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hioxifilcon A (Test) | The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets. | -2.16 -10 x logMAR | Standard Deviation 0.606 |
| Hioxifilcon A (Control) | The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets. | -1.69 -10 x logMAR | Standard Deviation 0.727 |
Secondary
The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.
Time Controlled Visual Acuity (TCVA) was assessed at 67 cm using 50 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.
Time frame: 15 Minutes post lens fitting
Population: All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hioxifilcon A (Test) | The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets. | -1.29 -10 x logMAR | Standard Deviation 0.673 |
| Hioxifilcon A (Control) | The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets. | -1.04 -10 x logMAR | Standard Deviation 0.782 |