N/A
Completed N=252
Clinical Assessment of a HYDRAGLYDE® Regimen
Refractive errors · Myopia · Hypermetropia
Source: ClinicalTrials.gov NCT03026257 ↗
Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Ex Vivo Total Cholesterol Uptake at Day 30 — 0.28; 0.28; 2.17; 4.18 μg — p=<0.0001
Summary
The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ex Vivo Total Cholesterol Uptake at Day 30 |
0.28; 0.28; 2.17; 4.18; 2.07; 2.19 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Must sign informed consent document;
- Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses;
- Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add <+0.50 D in each eye;
- Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available;
- Current user of an MPS (excluding OFPM) to care for lenses;
- Willing to answer text messages on a daily basis during the study;
- Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits;
- Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study;
- Other protocol specific inclusion criteria may apply.
Exclusion Criteria
- Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week);
- Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear;
- History of herpetic keratitis, corneal surgery or irregular cornea;
- Prior refractive surgery;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days;
- Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Known pregnancy or lactating;
- Other protocol specific exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03026257). 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.