N/A
N=10
Novel Multifocal Soft Contact Lens Study
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT06172881 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Distance Visual Acuity — -0.13; -0.12 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational Contact Lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity |
-0.13; -0.12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ability to give informed consent
- Any gender
- Any racial or ethnic origin
- 18 - 40 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06172881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.