N/A
Completed N=41
The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens
Astigmatism
Source: ClinicalTrials.gov NCT02801006 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Comfort — 8.2; 7.4 units on a scale
Summary
The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort |
8.2; 7.4 | — |
| PRIMARY Dryness |
8.0; 7.4 | — |
| PRIMARY Clarity of Vision |
8.5; 7.8 | — |
| PRIMARY Stability of Vision |
8.6; 8.0 | — |
| PRIMARY Lens Handling |
8.8; 7.6; 7.2; 8.9 | — |
| PRIMARY Overall Satisfaction |
8.1; 7.2 | — |
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is between 18 years of age and 42 years of age.
- Soft contact lens wearers who are not required to have Presbyopic correction.
- Soft contact lens wearers without trouble.
- Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
- Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
- Can achieve a corrected visual acuity of 1.0 or better.
- Can read and understand the study information document, and sign the participation consent form.
- Can visit the clinic at designated examination visits.
- Has received periodical examinations at an eye clinic within the past two years.
Exclusion Criteria
A person will be excluded from the study if he/she:
- Has a systemic disease that may affect the ocular health.
- Is pregnant or lactating.
- Has received a systemic or local medication that may affect this study.
- Has an infectious eye disease.
- Has eye and systemic active allergic diseases that interferes with SCL wear.
- Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder
- Has a history of hard contact lens wear within 30 days.
- Is currently participating in another clinical research study.
- Has undergone refractive surgery.
Data sourced from ClinicalTrials.gov (NCT02801006). 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.