N/A
N=132
Clear Care® Plus vs. PeroxiClear™
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02413333 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Mean Residual Peroxide at Day 30 — 229.7; 26.2 parts per million (ppm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clear Care Plus contact lens solution (Device); PeroxiClear contact lens solution (Device); Silicone hydrogel contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Residual Peroxide at Day 30 |
229.7; 26.2 | — |
| SECONDARY Mean Osmolality in Lens Cases at Day 30 |
345.1; 299.2 | — |
Summary
The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.
Eligibility Criteria
Inclusion Criteria
- Sign informed consent form;
- Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
- Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
- Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Current hydrogen peroxide-based solution user;
- Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02413333). 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.