Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Time to Restore Central Corneal Thickness [48 hours]
Time (hours) to restore central corneal thickness to its baseline value after lens removal
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University | Bloomington | Indiana | United States | 47405 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-002
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Study Group 1 |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 38 |
| COMPLETED | 30 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | Study Group 1 |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 38 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
21.4
(2.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
23
60.5%
|
| Male |
15
39.5%
|
Outcome Measures
| Title | Percent Change in Central Corneal Thickness |
|---|---|
| Description | Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed) |
| Time Frame | 8 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Study Group 1 |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 38 |
| Visit 1 (without lens) |
4.01
(1.57)
|
| Visit 2 (with lens) |
5.57
(2.11)
|
| Title | Time to Restore Central Corneal Thickness |
|---|---|
| Description | Time (hours) to restore central corneal thickness to its baseline value after lens removal |
| Time Frame | 48 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Test Eye With Lens | Control Eye |
|---|---|---|
| Arm/Group Description | Test eye after lens removed | Control eye in subjects with lens in test eye |
| Measure Participants | 38 | 38 |
| 0 hours |
0
0%
|
5.3
NaN
|
| 1 hours |
34.2
90%
|
63.2
NaN
|
| 2 hours |
44.7
117.6%
|
23.7
NaN
|
| 3 hours |
15.8
41.6%
|
5.3
NaN
|
| 4 hours |
5.3
13.9%
|
2.6
NaN
|
| >4 hours |
0
0%
|
0
NaN
|
Adverse Events
| Time Frame | 2 days | |
|---|---|---|
| Adverse Event Reporting Description | Adverse events were not coded. Therefore, source vocabulary is not applicable. | |
| Arm/Group Title | Study Group 1 | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Study Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Study Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/38 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Study Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/38 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch Health |
| Phone | 585-338-6399 |
| robert.steffen@bausch.com |
- 14-002