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The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.
This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.
The primary outcome variable for this study is overall subjective comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test to Moist | Experimental | 1 week of Test DD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. |
|
| Moist to Test | Active Comparator | 1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test DD contact lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA) | Device | Daily disposable contact lens wear for 1 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall subjective comfort | Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses) | 1 week after contact lens wear |
| Overall subjective comfort | Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses) | 2 weeks after contact lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| End of day subjective comfort | Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses) | Visit 2 and 3 - Approximately 1 and 2 weeks, respectively |
| Subjective vision | Subjective vision rating on a scale of 0 (Not at all sharp/clear) to 10 (Sharp/Clear) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ross Eyecare | Atlanta | Georgia | 30324 | United States | ||
| Professional VisionCare |
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Randomized cross-over with 1 week of lens wear with each contact lens type.
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Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
| Visit 2 and 3 - Approximately 1 and 2 weeks, respectively |
| Overall subjective lens preference | Forced choice subjective preference for either lens type (1-Day ACUVUE® MOIST or Test DD contact lens) or no preference. i.e. three options presented and participant selects one option. | Visit 3 - After approximately 2 weeks of contact lens wear |
| Westerville |
| Ohio |
| 43081 |
| United States |
| Primary Eyecare Group | Brentwood | Tennessee | 37027 | United States |