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NCT06232590

Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

Completed NA Results posted Last updated 12 February 2025
What this trial tests

NA trial testing Control Lens (comfilcon A) in Presbyopia in 60 participants. Completed in 9 July 2024.

Timeline
23 February 2024
Primary endpoint
9 July 2024
9 July 2024

Quick facts

Lead sponsorCooperVision International Limited (CVIL)
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment60
Start date23 February 2024
Primary completion9 July 2024
Estimated completion9 July 2024
Sites5 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

CooperVision International Limited (CVIL) — full company profile →

Who can join

42 and older, any sex, with Presbyopia. 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.

Lens Handling for Insertion Primary · 1 month

Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.

GroupValue95% CI
Control Lens95± 9
Test Lens96± 8

Adverse events — posted to ClinicalTrials.gov

Time frame: Length of study, approximately 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Lens
Serious: 0/60 (0%)
Deaths: 0/60
Test Lens
Serious: 0/59 (0%)
Deaths: 0/59
Other adverse events (7 terms — click to expand)

ReactionSystemControl LensTest Lens
Small lymph cystsEye disorders
Subconjunctival hemorrhageEye disorders
Eye floatersEye disorders
Respiratory infectionRespiratory, thoracic and mediastinal disorders
Stomach distressGastrointestinal disorders
DepressionPsychiatric disorders
Primary care provider interventionSurgical and medical procedures

Data from ClinicalTrials.gov NCT06232590 adverse events section.

Sponsor's own description

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

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 Presbyopia

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/NCT06232590.

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