N/A
N=60
Clinical Validation of DACP Digital Design
Refractive Errors
Bottom Line
View on ClinicalTrials.gov: NCT03567005 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Distance Visual Acuity (VA) (logMAR, OU) — -0.11; -0.12 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nelfilcon A digital contact lenses (Device); Nelfilcon A contact lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity (VA) (logMAR, OU) |
-0.11; -0.12 | — |
| SECONDARY Overall Vision |
8.8; 8.9 | — |
Summary
The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.
Eligibility Criteria
Inclusion Criteria
- Willing and able to sign an IRB/IEC approved Informed Consent form;
- Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
- Experiencing symptoms of eye strain from using technology;
- Willing to wear study lenses each day;
- Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
- Willing to NOT use rewetting/lubricating drops at any time during the study;
- Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
- Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.
Exclusion Criteria
- Conditions, use of medications, injury, or surgery, as specified in the protocol;
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Monocular (only one eye with functional vision);
- Pregnant.
Data sourced from ClinicalTrials.gov (NCT03567005). 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.