N/A
Completed N=53
Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens
Source: ClinicalTrials.gov NCT01180985 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Visual Acuity Monocular — 53; 49; 49; 48 eyes
Summary
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity Monocular |
53; 49; 49; 48; 2; 4 | — |
| PRIMARY Visual Acuity Binocular |
0; 1; 31; 29; 21; 20 | — |
| PRIMARY Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. |
80.32; 82.76 | — |
| PRIMARY Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. |
62.75; 59.98 | — |
| SECONDARY Limbal Redness |
37; 36; 36; 42; 31; 26 | — |
| SECONDARY Bulbar Redness |
39; 37; 55; 59; 10; 8 | — |
| SECONDARY Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. |
80.32; 82.76 | — |
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 the 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 (NCT01180985). 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.