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NCT02871375

Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

Completed NA Results posted Last updated 2 July 2018
What this trial tests

NA trial testing Delefilcon A multifocal contact lenses in Refractive Error in 170 participants. Completed in 14 November 2016.

Timeline
30 August 2016
Primary endpoint
14 November 2016
14 November 2016

Quick facts

Lead sponsorAlcon, a Novartis Company
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment170
Start date30 August 2016
Primary completion14 November 2016
Estimated completion14 November 2016

Drugs / interventions tested

Conditions studied

Sponsor

Alcon, a Novartis Company — full company profile →

Who can join

Adults 40 to 65, any sex, with Refractive Error. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) Primary · 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.

GroupValue95% CI
DT1 MF-0.07± 0.10
Habitual MF-0.09± 0.10
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score Secondary · 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.

Period One
GroupValue95% CI
DT1 MF9.9± 5.4
Habitual MF17.0± 7.1
Period Two
GroupValue95% CI
DT1 MF11.6± 6.3
Habitual MF13.0± 6.2
Overall
GroupValue95% CI
DT1 MF10.7± 5.9
Habitual MF14.9± 6.9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Delefilcon A multifocal contact lenses

Trials testing the same drug.

Other recruiting trials for Refractive Error

Currently open trials in the same condition.

Other Alcon, a Novartis Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02871375.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing