MedPath

Novel Multifocal Soft Contact Lens Study

Not Applicable
Completed
Conditions
Myopia
Interventions
Device: Investigational Contact Lens
Registration Number
NCT06172881
Lead Sponsor
Ohio State University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
Inclusion Criteria
  1. Ability to give informed consent
  2. Any gender
  3. Any racial or ethnic origin
  4. 18 - 40 years of age
  5. Distance visual acuity with best corrected visual acuity of 20/25 with each eye
  6. Habitual soft contact lens wearer with myopia
  7. 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).
Exclusion Criteria
  1. Current or active ocular inflammation or infection as determined by the Investigator.
  2. Astigmatism > 0.75 D in either eye
  3. History of previous eye surgery
  4. Demonstration or history of corneal ectasia or keratoconus.
  5. Pregnant or lactating.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Distance Visual AcuityInvestigational Contact LensVisual acuity will be measured while participant's wear study lenses.
Primary Outcome Measures
NameTimeMethod
Distance Visual Acuity1 day (This is a single visit study)

LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Ohio State University College of Optometry

🇺🇸

Columbus, Ohio, United States

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