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NCT04403542

Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

Completed NA Results posted Last updated 22 August 2023
What this trial tests

NA trial testing Lehfilcon A contact lens in Refractive Errors in 36 participants. Completed in 31 August 2020.

Timeline
3 August 2020
Primary endpoint
31 August 2020
31 August 2020

Quick facts

Lead sponsorAlcon Research
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment36
Start date3 August 2020
Primary completion31 August 2020
Estimated completion31 August 2020
Sites3 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.

Distance Visual Acuity (VA) With Study Lenses Primary · Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit

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 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Day 1 Dispense
GroupValue95% CI
LID018869-0.03± 0.05
Biofinity-0.04± 0.06
Day 2 Follow-up
GroupValue95% CI
LID018869-0.03± 0.05
Biofinity-0.03± 0.05
Week 1 Follow-up/Exit
GroupValue95% CI
LID018869-0.03± 0.05
Biofinity-0.03± 0.05

Sponsor's own description

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

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 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/NCT04403542.

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