Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Study Coordinators
- Phone Number: 614-292-8858
- Email: OPT-EyeStudies@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University College of Optometry
-
Contact:
- Emma Grant
- Phone Number: 614-292-8858
- Email: OPT-EyeStudies@osu.edu
-
Contact:
- Emily Wagner
- Phone Number: 614-292-8858
- Email: OPT-EyeStudies@osu.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current soft toric contact lens wearer with long hours of wear
- Willing to follow the contact lens wearing schedule required by the study
- Vision 20/25 or better with current soft toric contact lenses
- Self-report completion of a comprehensive eye examination in the past two years
Exclusion Criteria:
- Have a history of corneal ocular surgery
- Have current ocular inflammation or infection as assessed by the study investigator who will complete the study
- Are past rigid contact lens wearers
- Have a history of being diagnosed with dry eye or ocular allergies
- Have known systemic health conditions that are thought to alter tear film physiology
- Have a history of viral eye disease
- Have a history of ocular surgery
- Have a history of severe ocular trauma
- Have a history of corneal dystrophies or degenerations
- Have active ocular infection or inflammation
- Are currently using isotretinoin-derivatives or ocular medications
- Are pregnant or breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Contact Lens Wear
All participants will be fit with the study contact lenses for astigmatism
|
All participants will be fit with the study lenses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comfort
Time Frame: Measured over 16 hours of wear
|
Proportion of participants with positive Visual Analog Scale (VAS, >50 on a 0-100 scale)
|
Measured over 16 hours of wear
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
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
- 20252462
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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