Comprehensive Assessment of Multiple Products (CAMP)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
- Device: somofilcon A lens
- Device: stenfilcon A lens
- Device: fanfilcon A lens
- Device: comfilcon A lens
- Device: verofilcon A lens
- Device: serafilcon A lens
- Device: lehfilcon A lens
- Device: delefilcon A lens
- Device: senofilcon A daily disposable lens
- Device: senofilcon A with blue light technology lens
- Device: senofilcon A bi-weekly lens
- Device: samfilcon A lens
- Device: kalilfilcon A lens
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jose A Vega, OD,MSc,PhD
- Phone Number: 9256213761
- Email: jvega2@coopervision.com
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47405
- Indiana University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 45 years (inclusive)
- Habitual soft spherical contact lens wearer (current prescription)
- Refractive error of -6.00 to -0.50DS or +0.50 to +6.00DS and less than or equal to 0.75DC as vertexed to the corneal plane
- Anisometropia no greater than 1.50D, based on vertexed manifest refraction spherical equivalent
- Can achieve visual acuity of at least 20/25 in each eye with spherical equivalent manifest refraction
Exclusion Criteria:
- Active anterior segment infection, inflammation or abnormality that would contraindicate contact lens wear
- Use of systemic or ocular medication that would contraindicate contact lens wear
- Used gas permeable/hard contact lenses (including orthokeratology) in the previous 3 months
- Participation in a contact lens or lens care product trial in the previous 30 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: somofilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear somofilcon A soft contact lens for 10 hours.
|
|
Experimental: stenfilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear stenfilcon A soft contact lens for 10 hours.
|
|
Experimental: fanfilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear fanfilcon A soft contact lens for 10 hours.
|
|
Experimental: comfilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear comfilcon A soft contact lens for 10 hours.
|
|
Experimental: verofilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear verofilcon A soft contact lens for 10 hours.
|
|
Experimental: serafilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear serafilcon A soft contact lens for 10 hours.
|
|
Experimental: lehfilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear lehfilcon A soft contact lens for 10 hours.
|
|
Experimental: delefilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear delefilcon A soft contact lens for 10 hours.
|
|
Experimental: senofilcon A lens daily disposable
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear senofilcon A soft contact lens for 10 hours.
|
|
Experimental: senofilcon A lens with blue light technology
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear senofilcon A soft contact lens for 10 hours.
|
|
Experimental: senofilcon A lens bi-weekly replacement
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear senofilcon A soft contact lens for 10 hours.
|
|
Experimental: samfilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear samfilcon A soft contact lens for 10 hours.
|
|
Experimental: kalifilcon A lens
Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.
|
Participants will be randomized to wear kalifilcon A soft contact lens for 10 hours.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
High contrast, high luminance binocular distance visual acuity
Time Frame: At the end of 10 hours of daily wear at dispensing
|
High contrast, high luminance binocular distance visual acuity (logMAR) will be measured at 10-hour visit.
|
At the end of 10 hours of daily wear at dispensing
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Pete Kollbaum, OD, PhD, Indiana University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- EX-MKTG-167
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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