Astigmatism
Conditions
Brief summary
The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.
Interventions
DEVICEetafilcon A toric contact lens with new wetting agent
Investigational toric contact lens made of etafilcon A material with a new wetting agent.
Marketed toric contact lens made of etafilcon A material.
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 40 Years
Healthy volunteers
No
Inclusion criteria
1. The subject must be between 18 and 40 years old. 2. The subject must have normal eyes. 3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 4. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. 5. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye. 6. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye. 7. The subject's refractive cylinder axis must be 180 +/- 30 in each eye. 8. The subject must be an adapted wearer of soft toric contact lenses in both eyes. 9. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye. 10. Subjects must already possess a wearable pair of spectacles. -
Exclusion criteria
1. Ocular or systemic allergies or disease that may interfere with contact lens wear. 2. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear. 3. Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. 4. Clinically significant tarsal abnormalities that might interfere with contact lens wear. 5. Any ocular infection. 6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. Pregnancy or lactation 8. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). 9. Diabetes 10. Strabismus -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prescription Equivalence | after 15 minutes of lens wear | Number of subjects whose prescription is the same for the two lenses tested. |
Countries
United States
Participant flow
Pre-assignment details
Due to test article shipment error, one clinical site did not receive control test article in a required cylinder and all screened/enrolled subject were unable to be fitted according to the protocol and were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Test article shipping error | 11 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 5.1 |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Prescription Equivalence
Number of subjects whose prescription is the same for the two lenses tested.
Time frame: after 15 minutes of lens wear
Population: All completed subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Prescription Equivalence | 34 participants |