North American Comfilcon A Clinical Study
1 other identifier
observational
182
1 country
4
Brief Summary
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2025
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2025
CompletedFirst Submitted
Initial submission to the registry
March 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 27, 2025
August 1, 2025
10 months
March 11, 2025
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Visual Performance (Visual Acuity)
Visual Performance will be measured using logMAR * High contrast, high illumination distance VA * High contrast, high illumination near VA
At the end of 2 hours of wear
Incidence of contact lens-related adverse events
Incidence of contact lens-related adverse events will be recorded from subjects
At the end of 2 hours of wear
Study Arms (5)
comfilcon A Sphere Lens Wearers
Habitual comfilcon A Sphere Lens Wearers
comfilcon A Toric Lens Wearers
Habitual comfilcon A Toric Lens Wearers
comfilcon A Multifocal Lens Wearers
Habitual comfilcon A Multifocal Lens Wearers
comfilcon A Multifocal Toric Lens Wearers
Habitual comfilcon A Multifocal Toric Lens Wearers
comfilcon A Energys Lens Wearers
Habitual comfilcon A Energys Lens Wearers
Interventions
Eligibility Criteria
Female or male subjects aged 8 to 75 years who are established contact lens wearers. Screen and enrol approximately 182 participants wearing comfilcon A lenses with the aim of achieving at least 160 in the per protocol analysis cohort.
You may qualify if:
- Age 8 to 75 years (inclusive).
- Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
- At least occasional overnight wear in the last 12 months.
You may not qualify if:
- \. Current participation in a contact lens or contact lens care product clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Berkeley
Berkeley, California, 94720, United States
ProCare Vision Center
Granville, Ohio, 43023, United States
Nittany Eye Associates
College, Pennsylvania, 16801, United States
Drs. McIntyre, Garza, Avila and Jurica, Optometrists
Corpus Christi, Texas, 78411, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meng C Lin, OD, PhD
University of Berkeley
- PRINCIPAL INVESTIGATOR
Katherine Bickle, Dr.
ProCare Vision Center
- PRINCIPAL INVESTIGATOR
Abigail G Harsch, Dr.
Nittany Eye Associates
- PRINCIPAL INVESTIGATOR
David Browning, Dr.
Drs. McIntyre, Garza, Avila and Jurica, Optometrists
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2025
First Posted
March 30, 2025
Study Start
February 5, 2025
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
August 27, 2025
Record last verified: 2025-08