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NCT04404725
Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
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Summary Quick facts Who can join Endpoints Results Adverse events Related trials Sources
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 sponsor CooperVision, Inc.
Phase NA
Status Completed
Study type INTERVENTIONAL
Allocation randomized
Design crossover
Masking single
Primary purpose treatment
Enrollment 64
Start date 6 August 2020
Primary completion 29 July 2021
Estimated completion 29 July 2021
Sites 7 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).
Group Value 95% CI Comfilcon A 8.6 ± 1.6 Samfilcon A 8.8 ± 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) Reaction System Comfilcon A Samfilcon A conjunctivitis Eye disorders — — Non-Ocular Event General disorders — — Infiltrative Keratitis Eye 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.
NCT04195581 — A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
· NA
· completed
NCT04005885 — A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
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NCT02625233 — Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses
· NA
· completed
NCT01180985 — Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens
· NA
· completed
Other recruiting trials for Astigmatism
Currently open trials in the same condition.
NCT07303920 — Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
· NA
· recruiting
NCT07284966 — Comfort and Vision With TOTAL30 Multifocal Lenses
· recruiting
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· NA
· recruiting
NCT07084844 — Patient Reported Outcomes With WaveLight Plus LASIK
· recruiting
NCT07140653 — Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
· Phase 4
· recruiting
Other CooperVision, Inc. trials
Trials by the same sponsor.
NCT06817785 — Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere
· NA
· completed
NCT06758076 — A Clinical Comparison of Two Soft Contact Lenses (C24-755)
· NA
· completed
NCT06590441 — Investigation of Wearing Compliance of Spectacles for Myopia Control
· completed
NCT06609018 — Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses
· NA
· completed
NCT06611410 — 1 Week Crossover Study Between Two Soft Contact Lenses
· NA
· completed
Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT04404725 (US National Library of Medicine, public domain)
Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor : as reported to ClinicalTrials.gov by CooperVision, Inc.
Last refreshed : 3 March 2022
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
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