N/A
N=80
Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02939170 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Incidence of Ocular Discomfort Device-related Adverse Events (AE) — 0; 1 Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delefilcon A Multifocal Contact Lenses with Molded Mark (Device); Delefilcon A Multifocal Contact Lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon, a Novartis Company
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Ocular Discomfort Device-related Adverse Events (AE) |
0; 1 | — |
| SECONDARY Ocular Staining |
62; 63; 14; 17; 4; 0 | — |
| SECONDARY Limbal Hyperemia |
60; 52; 20; 27; 0; 1 | — |
Summary
The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).
Eligibility Criteria
Inclusion Criteria
- Must sign an Informed Consent document;
- Current wearer of commercial DAILIES TOTAL1® contact lenses;
- Have spectacles in current prescription available to be worn in conjunction with the investigational product;
- Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
- Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;
- 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;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- History of herpetic keratitis, refractive surgery or irregular cornea;
- A pathologically dry eye that precludes contact lens wear;
- Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
- Monocular (only 1 eye with functional vision);
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02939170). 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.