Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

Refractive Error Clinical Trial

Official title:

DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871375
• Other study ID #: CLE914-P001
• Status: Completed
• Phase: N/A
• Start date: August 30, 2016
• Est. completion date: November 14, 2016

Study information

• Verified date: October 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 14, 2016
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A multifocal contact lenses
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
• Habitual multifocal contact lenses
Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon, a Novartis Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)	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.	Day 14, each product
Secondary	Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score	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.	Day 14, each product

External Links

•   Results from the Novartis Clinical Trial Results Website