Habitual Soft Contact Lens Use Clinical Trial
Official title:
Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses
Verified date | October 2021 |
Source | Bausch & Lomb Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 16, 2020 |
Est. primary completion date | September 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or older and have full legal capacity to volunteer. - Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. - No active ocular disease or allergic conjunctivitis. - Not using any topical ocular medications. - Willing and able to follow instructions. - Signed a statement of informed consent. Exclusion Criteria: - Participating in a conflicting study in the opinion of the Investigator. - Considered by the Investigator to not be a suitable candidate for participation. |
Country | Name | City | State |
---|---|---|---|
United States | Bausch and Lomb Site 01 | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Bausch & Lomb Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surface Refractive Index Shifts at 5 Minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. | 5 minutes | |
Primary | Surface Refractive Index Shifts at 10 Minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. | 10 minutes | |
Primary | Surface Refractive Index Shifts at 15 Minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. | 15 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04840563 -
Surface Refractive Index Shift and Lens Absorption/Adsorption of Tear Components of Kalifilcon A Lenses vs Dailies Total1 and Precision1
|
N/A |