N/A
Completed N=180
Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens
Source: ClinicalTrials.gov NCT01094730 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Lens Front Surface Deposits at Day 7 — 1.53; 1.53 dichotomized grading scale
Summary
The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Front Surface Deposits at Day 7 |
1.53; 1.53 | — |
| PRIMARY Lens Front Surface Deposits at Day 14 |
1.61; 1.67 | — |
| SECONDARY Subject Reported Overall Lens Comfort at Day 7 |
60.7787; 59.3206 | — |
| SECONDARY Subject Reported Overall Lens Comfort at Day 14 |
57.3230; 55.4675 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must be at least 18 years of age and no more than 39 years of age.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
- Any cylinder power must be ≤ -0.75D.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- The subject must read and sign the Statement of Informed Consent.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria
- Ocular or systemic allergies or disease which might interfere with contact lens wear.
- Systemic disease or use of medication which might interfere with contact lens wear.
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Pregnancy or lactation.
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Data sourced from ClinicalTrials.gov (NCT01094730). 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.