N/A
N=26
Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT02366910 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A — 1.59; 3.82 absolute WC change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- omafilcon A (Device); delefilcon A (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A |
1.59; 3.82 | — |
| PRIMARY Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A |
1.20; 3.38 | — |
| PRIMARY Moisture Retention (Mean) of Omafilcon A and Delefilcon A |
2.58; 11.5 | — |
| PRIMARY Moisture Retention (Median) of Omafilcon A and Delefilcon A |
1.98; 9.89 | — |
Summary
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
- Is able to wear lenses for at least 12 hours a day.
Exclusion Criteria
- Is participating in any concurrent clinical study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Has undergone refractive error surgery;
- *For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Data sourced from ClinicalTrials.gov (NCT02366910). 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.