Eye Dryness
Conditions
Brief summary
This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.
Interventions
DEVICEsenofilcon A
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
DEVICElotrafilcon B
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must be 18 years of age and less than 51 years of age; 2. The subject must have read and understood the Participant Information Sheet; 3. The subject must have read, signed and dated the Informed Consent; 4. The subject must be a current planned replacement soft contact lens wearer; 5. The subject must be a regular user of devices (computer, tablet and/or smart phone) for a minimum average of 5 ± 1 hours per day in a typical week 6. The subject must have a refractive error within the range of correction of both study contact lenses; 7. The subject must have a best-corrected visual acuity of 6/9 (20/30, 0.18 LogMAR) or better in each eye; 8. The subject must demonstrate an acceptable fit with both study contact lenses; 9. The subject must agree to wear their contact lenses as directed for the duration of the study (every day or for at least a minimum of five days per week for a minimum of six hours per day and be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule; 10. The subject must have normal eyes with the exception of the need for visual correction.
Exclusion criteria
1. Any known sensitivity or intolerance to any of the contact lenses or adjunct products to be used. 2. Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses). 3. Use of systemic or ocular concomitant medications which, as determined by the investigator, might contraindicate or interfere with contact lens wear. 4. Ocular anterior segment infection, inflammation, abnormality, or active disease, which would contraindicate contact lens wear. 5. Any moderate or severe ocular condition observed during slit lamp examination at the enrollment visit. 6. A history of herpetic keratitis, ocular surgery or irregular cornea(s). 7. Known pregnancy or lactation during the study period. 8. Enrollment of investigator's office staff, relatives, or members of their respective households. 9. Participation in any clinical trial within 30 days of the enrollment visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Kinetics | 8 hour post insertion | The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses. |
| Time Controlled Visual Acuity | 8 hours post insertion | The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17 LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3 LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units. |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 45 subjects were enrolled into this study. Of the enrolled subjects 43 were dispensed and 2 subjects did not meet the eligibility criteria. Of the 43 dispensed subjects, 1 subject was discontinued 42 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed at least one lens throughout the duration of the study. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 35.1 Years STANDARD_DEVIATION 7.78 |
| Region of Enrollment United Kingdom | 43 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 43 | 4 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Primary
Tear Film Kinetics
The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.
Time frame: 8 hour post insertion
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Tear Film Kinetics | 5.590 Seconds | Standard Deviation 4.2705 |
| Lotrafilcon B | Tear Film Kinetics | 6.941 Seconds | Standard Deviation 6.1257 |
Primary
Time Controlled Visual Acuity
The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17 LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3 LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.
Time frame: 8 hours post insertion
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A | Time Controlled Visual Acuity | Distance | -0.06 LogMAR | Standard Deviation 0.092 |
| Senofilcon A | Time Controlled Visual Acuity | Intermediate | 0.07 LogMAR | Standard Deviation 0.077 |
| Lotrafilcon B | Time Controlled Visual Acuity | Distance | -0.07 LogMAR | Standard Deviation 0.075 |
| Lotrafilcon B | Time Controlled Visual Acuity | Intermediate | 0.06 LogMAR | Standard Deviation 0.074 |