N/A
Completed N=44
Evaluation of Stenfilcon A Versus Etafilcon A
Source: ClinicalTrials.gov NCT01809834 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Participant's Subjective Rating of Comfort (Questionnaire) — 92; 91; 96; 93 units on a scale
Summary
Evaluation of two contact lenses
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant's Subjective Rating of Comfort (Questionnaire) |
92; 91; 96; 93; 91; 88 | — |
| PRIMARY Participant's Subjective Rating of Dryness (Questionnaire) |
86; 83; 83; 82 | — |
| PRIMARY Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) |
80; 86 | — |
| PRIMARY Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) |
97; 92; 94; 94 | — |
| PRIMARY Participant's Subjective Rating of Visual Quality (Questionnaire) |
92; 89; 89; 89 | — |
| PRIMARY Participant's Subjective Rating of Overall Preference (Questionnaire) |
-8; 5 | — |
| SECONDARY Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) |
0.69; 0.78; 1.51; 1.47; 1.06; 1.15 | — |
| SECONDARY Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) |
3.37; 3.44; 3.26; 3.40; 3.36; 3.48 | — |
| SECONDARY Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) |
-0.09; -0.08; -0.09; -0.08; -0.09; -0.08 | — |
| SECONDARY Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) |
-0.07; -0.06; -0.07; -0.07; -0.08; -0.07 | — |
| SECONDARY Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) |
0.08; 0.23; 0.47; 0.56; 0.23; 0.14 | — |
| SECONDARY Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) |
0.23; 0.21; 0.15; 0.11; 0.06; 0.06 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
- Has astigmatism less than or equal to -1.00D;
- Is an adapted soft contact lens wearer;
- Demonstrates an acceptable fit with the study lenses;
- Has no active anterior segment disease or known ocular disease.
Exclusion Criteria
- A person will be excluded from the study if he/she:
- Has never worn contact lenses before;
- Has any systemic disease affecting ocular health;
- Is using any systemic or topical medications that will affect ocular health;
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- Is aphakic;
- Has undergone corneal refractive surgery;
- Is participating in any other type of clinical or research study;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Data sourced from ClinicalTrials.gov (NCT01809834). 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.