N/A
Completed N=10
Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses
Habitual Soft Contact Lens Use
Source: ClinicalTrials.gov NCT04555031 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Surface Refractive Index Shifts at 5 Minutes — 1.4102; 1.4251; 1.4188; 1.3788 No units
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surface Refractive Index Shifts at 5 Minutes |
1.4102; 1.4251; 1.4188; 1.3788 | — |
| PRIMARY Surface Refractive Index Shifts at 10 Minutes |
1.4102; 1.4267; 1.4182; 1.3786 | — |
| PRIMARY Surface Refractive Index Shifts at 15 Minutes |
1.4105; 1.4238; 1.4188; 1.3793 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04555031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.