N/A
Completed N=166
Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal
Source: ClinicalTrials.gov NCT02871375 ↗Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) — -0.07; -0.09 logMAR
Summary
The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) |
-0.07; -0.09 | — |
| SECONDARY Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score |
9.9; 17.0; 11.6; 13.0; 10.7; 14.9 | — |
Eligibility Criteria
Inclusion Criteria
- Must sign an informed consent document;
- Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
- Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
- Requires lenses within the power range of study lenses to be fitted;
- Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance;
- Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
- Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Monocular (only one eye functional) or fit with only 1 lens;
- Fitted with monovision;
- Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Currently wearing DT1 MF contact lenses;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02871375). 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.