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NCT04404725

Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Completed NA Results posted Last updated 3 March 2022
What this trial tests

NA trial testing comfilcon A in Astigmatism in 64 participants. Completed in 29 July 2021.

Timeline
6 August 2020
Primary endpoint
29 July 2021
29 July 2021

Quick facts

Lead sponsorCooperVision, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment64
Start date6 August 2020
Primary completion29 July 2021
Estimated completion29 July 2021
Sites7 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

CooperVision, Inc.

Who can join

17 and older, any sex, with Astigmatism or 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.

Ease of Lens Handling at Insertion Primary · Day 28

Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).

GroupValue95% CI
Comfilcon A8.6± 1.6
Samfilcon A8.8± 1.8

Adverse events — posted to ClinicalTrials.gov

Time frame: One month on each study lenses, a total of two months.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Comfilcon A
Serious: 0/61 (0%)
Deaths: 0/61
Samfilcon A
Serious: 0/63 (0%)
Deaths: 0/63
Other adverse events (3 terms — click to expand)

ReactionSystemComfilcon ASamfilcon A
conjunctivitisEye disorders
Non-Ocular EventGeneral disorders
Infiltrative KeratitisEye disorders

Data from ClinicalTrials.gov NCT04404725 adverse events section.

Sponsor's own description

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

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 comfilcon A

Trials testing the same drug.

Other recruiting trials for Astigmatism

Currently open trials in the same condition.

Other CooperVision, Inc. 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/NCT04404725.

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