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NCT06119191

Clinical Evaluation of Reusable Soft Contact Lenses

Completed NA Results posted Last updated 8 April 2025
What this trial tests

NA trial testing Control Lenses (comfilcon A with current process) in Myopia in 77 participants. Completed in 1 March 2024.

Timeline
14 November 2023
Primary endpoint
1 March 2024
1 March 2024

Quick facts

Lead sponsorCooperVision International Limited (CVIL)
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment77
Start date14 November 2023
Primary completion1 March 2024
Estimated completion1 March 2024
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

CooperVision International Limited (CVIL) — full company profile →

Who can join

18 and older, any sex, with 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.

Visual Acuity Primary · 4 weeks

Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.

GroupValue95% CI
Control Lenses-0.07± 0.08
Test Lenses-0.13± 0.08

Adverse events — posted to ClinicalTrials.gov

Time frame: Length of study, approximately 30±2 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Lenses
Serious: 0/26 (0%)
Deaths: 0/26
Test Lenses
Serious: 0/48 (0%)
Deaths: 0/48
Other adverse events (1 terms — click to expand)

ReactionSystemControl LensesTest Lenses
Ocular Hyperemia and DiscomfortEye disorders

Data from ClinicalTrials.gov NCT06119191 adverse events section.

Sponsor's own description

The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.

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 Myopia

Currently open trials in the same condition.

Other CooperVision International Limited (CVIL) 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/NCT06119191.

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