Corneal Deformity
Conditions
Brief summary
This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.
Interventions
The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
Sponsors
Bausch & Lomb Incorporated
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
* Be between 18 and 40 years of age (inclusive) * Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months) * Able to read, comprehend and sign an informed consent * Willing to comply with the wear and study visit schedule * Monocular best-corrected distance visual acuity \>/-20/25 in each eye
Exclusion criteria
* Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear * Systemic or ocular allergies, which might interfere with contact lens wear * Systemic disease or condition, which might interfere with contact lens wear * Use of prescription sleep aids or alcohol within 24 hours of study appointment * Inability to wear contact lenses * Under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Central Corneal Thickness | 8 hours | Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Restore Central Corneal Thickness | 48 hours | Time (hours) to restore central corneal thickness to its baseline value after lens removal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group 1 1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens
B&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Study Group 1 |
|---|---|
| Age, Continuous | 21.4 years STANDARD_DEVIATION 2.8 |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Percent Change in Central Corneal Thickness
Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)
Time frame: 8 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group 1 | Percent Change in Central Corneal Thickness | Visit 1 (without lens) | 4.01 milimeters | Standard Deviation 1.57 |
| Study Group 1 | Percent Change in Central Corneal Thickness | Visit 2 (with lens) | 5.57 milimeters | Standard Deviation 2.11 |
Secondary
Time to Restore Central Corneal Thickness
Time (hours) to restore central corneal thickness to its baseline value after lens removal
Time frame: 48 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 | Time to Restore Central Corneal Thickness | 0 hours | 0 percentage of participants |
| Study Group 1 | Time to Restore Central Corneal Thickness | 1 hours | 34.2 percentage of participants |
| Study Group 1 | Time to Restore Central Corneal Thickness | 2 hours | 44.7 percentage of participants |
| Study Group 1 | Time to Restore Central Corneal Thickness | 3 hours | 15.8 percentage of participants |
| Study Group 1 | Time to Restore Central Corneal Thickness | 4 hours | 5.3 percentage of participants |
| Study Group 1 | Time to Restore Central Corneal Thickness | >4 hours | 0 percentage of participants |
| Control Eye | Time to Restore Central Corneal Thickness | 4 hours | 2.6 percentage of participants |
| Control Eye | Time to Restore Central Corneal Thickness | 0 hours | 5.3 percentage of participants |
| Control Eye | Time to Restore Central Corneal Thickness | 3 hours | 5.3 percentage of participants |
| Control Eye | Time to Restore Central Corneal Thickness | 1 hours | 63.2 percentage of participants |
| Control Eye | Time to Restore Central Corneal Thickness | >4 hours | 0 percentage of participants |
| Control Eye | Time to Restore Central Corneal Thickness | 2 hours | 23.7 percentage of participants |