Novel Multifocal Soft Contact Lens Study
1 other identifier
interventional
10
1 country
1
Brief Summary
A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
November 29, 2023
CompletedStudy Start
First participant enrolled
December 14, 2023
CompletedFirst Posted
Study publicly available on registry
December 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2024
CompletedResults Posted
Study results publicly available
May 1, 2024
CompletedMay 1, 2024
April 1, 2024
29 days
November 29, 2023
April 1, 2024
April 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Distance Visual Acuity
LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.
1 day (This is a single visit study)
Study Arms (1)
Distance Visual Acuity
EXPERIMENTALVisual acuity will be measured while participant's wear study lenses.
Interventions
A soft contact lens that will be worn only at the study visit.
Eligibility Criteria
You may qualify if:
- Ability to give informed consent
- Any gender
- Any racial or ethnic origin
- years of age
- Distance visual acuity with best corrected visual acuity of 20/25 with each eye
- Habitual soft contact lens wearer with myopia
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the investigator).
You may not qualify if:
- Current or active ocular inflammation or infection as determined by the Investigator.
- Astigmatism \> 0.75 D in either eye
- History of previous eye surgery
- Demonstration or history of corneal ectasia or keratoconus.
- Pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- Myoptechscollaborator
Study Sites (1)
The Ohio State University College of Optometry
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jennifer Fogt, OD, MS
- Organization
- The Ohio State University College of Optometry
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Fogt, OD, MS
The Ohio State University College of Optometry
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
November 29, 2023
First Posted
December 15, 2023
Study Start
December 14, 2023
Primary Completion
January 12, 2024
Study Completion
January 12, 2024
Last Updated
May 1, 2024
Results First Posted
May 1, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share