Myopia
Conditions
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.
Interventions
A soft contact lens that will be worn only at the study visit.
Sponsors
Myoptechs
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity | 1 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Distance Visual Acuity Visual acuity will be measured while participant's wear study lenses.
Investigational Contact Lens: A soft contact lens that will be worn only at the study visit. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Distance Visual Acuity |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous Age | 29.3 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: 1 day (This is a single visit study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Distance Visual Acuity | Distance Visual Acuity | High Contrast Distance Visual Acuity OD | -0.13 logMAR | Standard Deviation 0.08 |
| Distance Visual Acuity | Distance Visual Acuity | High Contrast Distance Visual Acuity OS | -0.12 logMAR | Standard Deviation 0.09 |