N/A
Completed N=43
Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
Source: ClinicalTrials.gov NCT02024698 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Comfort (Subjective Assessment) — 9.12; 9.16 units on a scale
Summary
The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort (Subjective Assessment) |
9.15; 8.65; 8.12; 8.63; 7.20; 7.70 | — |
| PRIMARY Hydration (Subjective Assessment) |
9.41; 8.84; 8.02; 8.47; 7.32; 7.53 | — |
| PRIMARY Vision Quality (Subjective Assessment) |
9.33; 9.16 | — |
| PRIMARY Vision Satisfaction (Subjective Assessment) |
9.07; 9.05 | — |
| PRIMARY Dryness (Subjective Assessment) |
8.05; 8.58; 7.24; 7.70; 7.71; 8.14 | — |
| PRIMARY Handling (Subjective Assessment) |
8.85; 8.44; 8.85; 8.51 | — |
| PRIMARY Eye Whiteness/Redness (Subjective Assessment) |
8.63; 9.26 | — |
| PRIMARY Overall Sensation of Smoothness (Subjective Assessment) |
25; 24; 11; 7; 2; 9 | — |
| PRIMARY Overall Satisfaction for Lens |
17; 21; 18; 14; 5; 7 | — |
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive)
- Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
- Has had a self-reported visual exam in the last two years
- Is an adapted soft CL (Contact Lens) wearer
- Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has less than 0.75D (Diopters) spectacle cylinder in each eye.
- Is correctable to a visual acuity of 20/25 or better in both eyes
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Is willing to comply with the wear schedule (at least 40 hrs per week)
- Is willing to comply with the visit schedule
Exclusion Criteria
A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to -6.00D
- Has a spectacle cylinder greater than -0.50D of cylinder in either eye.
- Has best corrected spectacle distance vision worse then 20/25 in either eye.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion
- Has persistent, clinically significant corneal or conjunctival staining
- Has active neovascularization or any central corneal scars.
- Is aphakic.
- Is presbyopic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT02024698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.