Trial Outcomes & Findings for 1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses (NCT NCT06053736)
NCT ID: NCT06053736
Last Updated: 2026-08-25
Results Overview
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.
COMPLETED
NA
32 participants
1-Week Follow-up Visit (approximately 7 ± 3 days after the dispensing visit)
2026-08-25
Participant Flow
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.
32 subjects were enrolled. Three subjects were discontinued before study lenses were dispensed.
Participant milestones
| Measure |
REVIVE™ Toric Soft Contact Lenses
All enrolled subjects; assigned to wear REVIVE™ Toric soft contact lenses bilaterally for approximately 1 week.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
REVIVE™ Toric Soft Contact Lenses
All enrolled subjects; assigned to wear REVIVE™ Toric soft contact lenses bilaterally for approximately 1 week.
|
|---|---|
|
Overall Study
Torn lens resulted in missed visit.
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
All 32 enrolled participants.
Baseline characteristics by cohort
| Measure |
REVIVE™ Toric Soft Contact Lenses
n=32 Participants
REVIVE Toric Soft Contact Lens; All participants received Revive toric contact lens to wear in each eye for one week.
|
|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 11.51 • n=31 Participants • All 32 enrolled participants.
|
|
Sex: Female, Male
Female
|
15 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Sex: Female, Male
Male
|
17 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Race (NIH/OMB)
White
|
28 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=31 Participants • All 32 enrolled participants.
|
|
Region of Enrollment
United States
|
32 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-up Visit (approximately 7 ± 3 days after the dispensing visit)Population: The participants who completed the study with the test lens and had 1-week follow-up visual acuity measured binocularly (26 participants )
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.
Outcome measures
| Measure |
REVIVE™ Toric Soft Contact Lenses
n=26 Participants
All participants wore REVIVE™ Toric soft contact lenses (hioxifilcon D) bilaterally for approximately 1 week
|
|---|---|
|
Mean logMAR Visual Acuity at 6m
|
-0.131 logMAR
Standard Deviation 0.0774
|
Adverse Events
REVIVE™ Toric Soft Contact Lenses
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
REVIVE™ Toric Soft Contact Lenses
n=32 participants at risk
All participants wore REVIVE™ Toric soft contact lenses (hioxifilcon D) bilaterally for approximately 1 week
|
|---|---|
|
Eye disorders
Eye pain / irritation (left eye), unrelated
|
3.1%
1/32 • Number of events 1 • From enrollment through the 1-week follow-up (approximately 1-2 weeks per participant).
No deaths, serious adverse events, or serious adverse device effects occurred. One non-serious adverse event (eye pain/irritation), unrelated to the test article, was reported. Three device deficiencies (torn lenses) occurred with no associated injury or adverse device effect.
|
Additional Information
Jeffery Schafer, OD, MS Director, Clinical Research
Bausch + Lomb
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place