N/A
Completed N=71
Clinical Performance Comparison of Several Different Contact Lenses
Source: ClinicalTrials.gov NCT00912028 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Limbal Hyperemia (Redness) — 40; 14; 24; 12 eyes
Summary
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Limbal Hyperemia (Redness) |
46; 16; 18; 10; 4; 12 | — |
| PRIMARY Limbal Hyperemia (Redness) |
46; 16; 18; 10; 4; 12 | — |
| PRIMARY Bulbar Hyperemia (Redness) |
45; 11; 23; 12; 13; 9 | — |
| PRIMARY Bulbar Hyperemia (Redness) |
45; 11; 23; 12; 13; 9 | — |
| PRIMARY Corneal Staining |
33; 8; 10; 19; 16; 18 | — |
| PRIMARY Corneal Staining |
33; 8; 10; 19; 16; 18 | — |
Eligibility Criteria
Inclusion Criteria
Subjects must:
- be existing soft contact lens wearers of the study control lenses
- require a distance visual correction in both eyes
- have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
- have astigmatism less than or equal to 1.00D in both eyes
- be able to wear lenses available for this study
- be corrected to a visual acuity of 6/9 (20/30) or better in each eye
- have normal eyes with no evidence of abnormality or disease
Exclusion Criteria
Subject are excluded for the following reasons:
- monovision corrected
- worn lenses extended wear in the last 3 months.
- require concurrent ocular medication
- grade 3 or 4 abnormalities
- grade 3 corneal staining in more than two regions
- anterior ocular surgery
- any other ocular surgery or injury within 8 weeks prior to study enrollment
- abnormal lachrymal secretions
- pre-existing ocular irritation that would preclude contact lens fitting
- corneal irregularities
- Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
- any systemic illness which would preclude contact lens wear
- diabetes
- infectious or immunosuppressive disease
- pregnancy or lactating, or planning pregnancy at time or enrollment
- participating in a concurrent clinical study or within last 60 days
- allergy to the standardized study care solution
Data sourced from ClinicalTrials.gov (NCT00912028). 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.