Phase 4
Completed N=24
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Source: ClinicalTrials.gov NCT03881670 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Higher Order Aberrations — 0.001646; 0.002629 microns
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Higher Order Aberrations |
0.001646; 0.002629 | — |
| SECONDARY Subjective Stability of Vision Rating |
-5.833; -2.500 | 0.0023 sig |
| SECONDARY Image Quality Metrics |
0.015134; 0.013899 | — |
Eligibility Criteria
Inclusion Criteria
- Habitual prescription +5.00 D to -6.00 D
- 18-35 years of age
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Vertex corrected refractive cylinder must be -0.75 or less.
- Visual acuity best correctable to 20/25 or better for each eye
- The subject must read and sign the Informed Consent form.
- Mesopic pupil size >5.00 mm.
Exclusion Criteria
- active condition that would prevent contact lens wear
- history of issues of eye alignment or binocularity by self-report
- doctor diagnosed, self-reported accommodative or binocular vision issues
- doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
Data sourced from ClinicalTrials.gov (NCT03881670). 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.