N/A
Completed N=75
Comparison of Lotrafilcon B Lenses With Different Packaging Solutions
Source: ClinicalTrials.gov NCT02699684 ↗Enrolled (actual)
75
Serious AEs
0.4%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes — 93.3; 94.6 percentage of subjects
Summary
The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes |
93.3; 94.6 | — |
| SECONDARY Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear |
0.44; 0.27 | — |
| SECONDARY Change From Insertion in Minimum Protected Area (MPA) |
86.839; 4.396 | — |
Eligibility Criteria
Inclusion Criteria
- Must sign Informed Consent Document;
- Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
- Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
- Willing to answer text messages on a daily basis during the study;
- Willing to discontinue artificial tears and rewetting drops on the days of study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
- Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
- History of herpetic keratitis, corneal surgery or irregular cornea;
- Any 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;
- Pregnant or lactating;
- Participation in any clinical study within 30 days of Visit 1;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02699684). 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.