Trials Sponsors Conditions Drugs Pricing

Conditions

Astigmatism Presbyopia

Outcome Measures

Primary Outcomes (1)

Ease of Lens Handling at Insertion
Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).
Day 28

Study Arms (2)

comfilcon A then samfilcon A

EXPERIMENTAL

Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.

Device: comfilcon ADevice: Samfilcon A

samfilcon A then comfilcon A

ACTIVE COMPARATOR

Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.

Device: comfilcon ADevice: Samfilcon A

Interventions

comfilcon ADevice

Subjects will be randomized to wear comfilcon A for one month.

Also known as: Biofinity Toric Multifocal

comfilcon A then samfilcon Asamfilcon A then comfilcon A

Samfilcon ADevice

Subjects will be randomized to wear samfilcon A for one month.

Eligibility Criteria

Age17 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Is at least 42 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;

Sponsors & Collaborators

CooperVision, Inc.
Industrylead

Study Sites (7)

Athens Eye care

Athens, Ohio, 45701, United States

Nittany Eye Associates

State College, Pennsylvania, 16801, United States

Glasses Half Full

Edmonton, Alberta, T5N1S5, Canada

Oakley Eyecare

Winnipeg, Manitoba, R2C 3B4, Canada

Dolman Eyecare Centre

New Hamburg, Ontario, N3A 1K2, Canada

Spadina Optometry

Toronto, Ontario, M5V 2K8, Canada

Lyndon Jones

Waterloo, Ontorio, N2L 3G1, Canada

MeSH Terms

Conditions

AstigmatismPresbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title: Jose Vega, OD, MSc, FAAO
Organization: CooperVision, Inc

Study Officials

Lyndon Jones, PhD FCOptom
University of Waterloo
PRINCIPAL INVESTIGATOR
Fiona Soong
Eyes on Sheppard Clinic
PRINCIPAL INVESTIGATOR
Adam Keech
Oakley Eyecare
PRINCIPAL INVESTIGATOR
Howard Dolman
Dolman Eyecare Centre
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

64 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 27, 2020

Study Start

August 6, 2020

Actual (reported)

Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

comfilcon A then samfilcon A

samfilcon A then comfilcon A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

comfilcon A then samfilcon A

samfilcon A then comfilcon A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations