N/A
Completed N=33
Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
Source: ClinicalTrials.gov NCT03372551 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Comfort — 90; 89; 86; 87 score on a scale
Summary
The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort |
90; 89; 86; 87; 84; 86 | — |
| PRIMARY Preference |
5; 9; 1; 5; 12 | — |
| PRIMARY Vision |
-0.10; -0.10; -0.11; -0.11; -0.15; -0.15 | — |
| PRIMARY Subjective Vision |
92; 92; 88; 91 | — |
| PRIMARY Corneal Staining |
0.16; 0.16; 0.20; 0.18 | — |
| PRIMARY Conjunctival Staining |
0.20; 0.20; 0.72; 0.91 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has had a self-reported oculo-visual examination in the last two years;
- Has read, understood, and signed the information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
- Must be able to achieve 20/30 or better (in each eye) with the study lenses;
- Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
- Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
- Has no more than 0.75 diopters of refractive astigmatism;
- Has clear corneas and no active* ocular disease;
- Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria
- Is presently participating in any other clinical or research study including eye related clinical or research study;
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
- Has any known sensitivity to fluorescein dye or products to be used in the study.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Data sourced from ClinicalTrials.gov (NCT03372551). 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.