Myopia
Conditions
Brief summary
The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.
Interventions
DEVICESofLens Daily Disposable
Lenses to be worn for 8-16 hours
DEVICEMarketed 1 Day Contact Lens
Lenses to be worn for 8-16 hours
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * Have no active ocular disease or allergic conjunctivitis. * Not be using any topical ocular medications.
Exclusion criteria
* Participating in a conflicting study. * Considered by the Investigator to not be a suitable candidate for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance | Insertion, 4 hours & End of Day | Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SofLens Daily Disposable SofLens Daily Disposable Lenses
SofLens Daily Disposable: Lenses to be worn for 8-16 hours | 14 |
| Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens
Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 2 |
Baseline characteristics
| Characteristic | SofLens Daily Disposable | Marketed 1 Day Contact Lens | Total |
|---|---|---|---|
| Age, Continuous | 40 years | 40 years | 40 years |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Clinical Performance
Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.
Time frame: Insertion, 4 hours & End of Day
Population: All eligible participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SofLens Daily Disposable | Clinical Performance | Lens Insertion | 98.1 units on a scale |
| SofLens Daily Disposable | Clinical Performance | 4 Hours after insertion | 97.5 units on a scale |
| SofLens Daily Disposable | Clinical Performance | End of Day (8-16 hours) | 91.9 units on a scale |
| Marketed 1 Day Contact Lens | Clinical Performance | Lens Insertion | 100 units on a scale |
| Marketed 1 Day Contact Lens | Clinical Performance | 4 Hours after insertion | 98.1 units on a scale |
| Marketed 1 Day Contact Lens | Clinical Performance | End of Day (8-16 hours) | 91.7 units on a scale |