N/A
N=80
Initial Performance of a Modified Daily Disposable Contact Lens
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02694835 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) — 0; 0 Eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delefilcon A contact lenses with UV Absorber (Device); Delefilcon A contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) |
0; 0 | — |
Summary
The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.
Eligibility Criteria
Inclusion Criteria
- Must sign an Informed Consent document;
- Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
- Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
- Manifest astigmatism less than or equal to 0.75 D (at screening);
- Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Eye injury in either eye within 12 weeks prior to study enrollment;
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
- History of herpetic keratitis;
- History of refractive surgery or irregular cornea;
- Pathologically dry eye that precludes contact lens wear;
- Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
- Monocular (only 1 eye with functional vision);
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02694835). 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.