N/A
Completed N=41
Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
Source: ClinicalTrials.gov NCT05516082 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Lens Fit Acceptance — 3.51; 3.68 score on a scale
Summary
This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit Acceptance |
3.51; 3.68 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and signed an information consent letter.
- Self-reports having a full eye examination in the previous two years.
- Anticipates being able to wear the study lenses for the required time of the study.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Has refractive astigmatism no higher than -0.75 DC.
- Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
- Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.
Exclusion Criteria
- Is participating in any concurrent clinical or research study.
- Has any known active ocular disease and/or infection that contraindicates contact lens wear.
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
- Has known sensitivity to the diagnostic sodium fluorescein used in the study.
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
- Has undergone refractive error surgery or intraocular surgery.
Data sourced from ClinicalTrials.gov (NCT05516082). 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.