Astigmatism Bilateral
Conditions
Brief summary
This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
Interventions
DEVICEOne week replacement soft contact lenses
One week replacement soft contact lenses
Sponsors
Ohio State University
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be fit into the one week replacement soft contact lens to wear for 3 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses) 2. Subjects must have 20/20 or better best corrected visual acuity. 3. 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 PI) 4. Ability to give informed consent 5. Willing to spend time for the study. Subjects will be required to attend three study visits and wear contact lenses on days between study visits. 6. Willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear. 7. Currently not using eye lubricating drops and willing to not use during study. 8. Either gender and 18-40 years of age. 9. Any racial or ethnic origin
Exclusion criteria
1. Any active ocular inflammation or infection. 2. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. 3. Are presbyopic and require or habitually uses reading glasses for near work 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable 5. History of refractive surgery 6. Meets the diagnosis of dry eye disease with OSDI screening score ≥13. 7. Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein 8. Is pregnant or lactating or planning a pregnancy during enrollment in the study 9. Is participating in another clinical research study that includes invasive ocular tests 10. An inability to perform contact lens application and removal after instruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Assessment of Lens Wear Experience | After 3 weeks of lens wear | VAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent) |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 27.25 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 24 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 3 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed