N/A
Completed N=53
Comparison of New Contact Lens With Current Marketed Lens
Source: ClinicalTrials.gov NCT03360110 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Corneal Staining Extent — 0.04; 0.04 units on a scale
Summary
The purpose of this study is to validate the clinical performance of a new contact lens design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Staining Extent |
0.07; 0.07 | — |
| PRIMARY Conjunctival Staining Score |
0.26; 0.29 | — |
| PRIMARY Palpebral Hyperemia on Upper Lid |
1.05; 1.06 | — |
| PRIMARY Palpebral Hyperemia on Lower Lid |
1.05; 1.06 | — |
| PRIMARY Palpebral Roughness Grade - Upper Lid |
1.26; 1.20 | — |
| PRIMARY Palpebral Roughness Grade - Lower Lid |
1.23; 1.20 | — |
| SECONDARY Distance Visual Acuity |
-0.23; -0.22; -0.04; -0.04 | — |
| SECONDARY Near Visual Acuity |
-0.17; -0.19; 0.06; 0.04 | — |
| SECONDARY Vision Quality Rating |
9.3; 9.2 | — |
Eligibility Criteria
Inclusion criteria
A person is eligible for inclusion in the study if he/she:
- Between and 18 and 35 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 and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Has a Contact Lens Refraction between -1.00D and -6.00D
- Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
- Currently wears soft contact lenses
- Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
- Has clear corneas and no active ocular disease
- Has not worn lenses for at least 12 hours before the first visit
Exclusion Criteria
A person will be excluded from the study if he/she:
- Has never worn contact lenses before
- Is wearing Monovision modality
- 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, active neovascularization or any central corneal scars
- Is aphakic
- Has undergone corneal refractive surgery
- Is participating in any other type of eye related clinical or research study
Data sourced from ClinicalTrials.gov (NCT03360110). 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.