Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

Not Applicable

Completed

• Conditions: Refractive Error

• Registration Number: NCT02871375
• Lead Sponsor: Alcon, a Novartis Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-18
• Study Start: 2016-08-30
• Primary Completion: 2016-11-14
• Study Completion: 2016-11-14
• Results First Submitted: 2017-09-22
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-20
• Results First Posted: 2017-11-24
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)	Day 14, each product	Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score	Day 14, each product	The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.