Astigmatism, Refractive Ametropia
Conditions
Keywords
REVIVE™, toric, soft contact lens, astigmatism, dispensing
Brief summary
Experienced soft contact lens wearing subjects were enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects were seen for a Screening/Dispensing Visit at which informed consent was obtained and eligibility was assessed. If subjects satisfied all eligibility criteria and none of the exclusion criteria, subjects were fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses were trialed. Once vision and lens fit were determined to be acceptable, eligible subjects wore study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses were worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements were taken at the insertion visit and at the 7-day follow-up visit.
Interventions
DEVICEREVIVE Toric Soft Contact Lenses
Subjects wore REVIVE™ Toric soft (hioxifilcon D) contact lenses bilaterally on a daily-wear (8-16 hours/day), planned-replacement basis for approximately 1 week.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All subjects wore the same test lens (REVIVE™ Toric) for approximately 1 week.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent. 2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. 3. Have no active ocular disease or allergic conjunctivitis. 4. Not be using any topical ocular medications. 5. Be willing and able to follow instructions. 6. Have signed a statement of informed consent
Exclusion criteria
1. Participating in a conflicting study in the opinion of the Investigator. 2. Considered by the Investigator to not be a suitable candidate for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean logMAR Visual Acuity at 6m | 1-Week Follow-up Visit (approximately 7 ± 3 days after the dispensing visit) | Mean binocular high-contrast, high-illumination (HCHI) logMAR visual acuity at 6 meters, measured with the REVIVE™ Toric study contact lenses in place at the 1-week follow-up visit. Acuity was recorded on a logMAR chart (each letter = 0.02 logMAR); lower/more-negative values indicate better visual acuity. |
Countries
United States
Contacts
STUDY_DIRECTORJeffery Schafer
Bausch & Lomb Incorporated
Participant flow
Recruitment details
Recruitment Details Subjects were recruited and screened at a single site (Bausch & Lomb, Rochester, NY). First enrolled Oct 4, 2023; last exited Dec 15, 2023.
Pre-assignment details
32 subjects were enrolled. Three subjects were discontinued before study lenses were dispensed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 11.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 28 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 1 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
None listed