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NCT04207749

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Completed NA Results posted Last updated 2 February 2022
What this trial tests

NA trial testing LID015385 contact lenses in Refractive Errors in 249 participants. Completed in 17 December 2020.

Timeline
22 January 2020
Primary endpoint
17 December 2020
17 December 2020

Quick facts

Lead sponsorAlcon Research
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment249
Start date22 January 2020
Primary completion17 December 2020
Estimated completion17 December 2020
Sites18 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Alcon Research — full company profile →

Who can join

18 and older, any sex, with Refractive Errors or Myopia. 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.

Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) Primary · Week 1 Follow-Up

Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.

GroupValue95% CI
Biofinity-0.06± 0.00
LID015385-0.05± 0.00
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009) Secondary · Week 1 Follow-Up, at least 4 hours after lens insertion

Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight.

GroupValue95% CI
Biofinity98.1
LID01538597.0

Sponsor's own description

The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.

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 LID015385 contact lenses

Trials testing the same drug.

Other recruiting trials for Refractive Errors

Currently open trials in the same condition.

Other Alcon Research 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/NCT04207749.

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