N/A
Completed N=38
Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens
Source: ClinicalTrials.gov NCT01192542 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Monocular Visual Acuity Assessment — -0.05; -0.04 logMAR
Summary
The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular Visual Acuity Assessment |
-0.05; -0.04 | — |
| PRIMARY Binocular Visual Acuity |
-0.08; -0.08 | — |
| SECONDARY Limbal Redness of Grade 3 or Above |
0; 0 | — |
| SECONDARY Bulbar Redness of Grade 3 or Above |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
- 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 (NCT01192542). 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.