N/A
Completed N=183
Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
Source: ClinicalTrials.gov NCT01669629 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Subject Reported Ease of Removal — 47.2; 75.6 percentage of participants
Summary
This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a primary hypothesis of comparing the handling of each lens. Additional secondary markers are measured looking at subjective comfort and vision of the lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Reported Ease of Removal |
47.2; 75.6 | — |
| SECONDARY Subject Reported Overall Comfort |
71.1; 61.1 | — |
| SECONDARY Subject Reported Overall Vision |
76.1; 72.2 | — |
| SECONDARY Binocular Snellen Visual Acuity |
95.0; 94.7 | — |
| SECONDARY Overall Corneal Staining |
19.4; 11.9 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
- The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week.
- The subject must be a current successful soft contact lens wearer in both eyes
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye.
- The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes.
- The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
- The subject must require a visual correction in both eyes (no monofit or monovision allowed).
- The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia.
- No evidence of lid abnormality or infection (including blepharitis/meibomitis).
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
- No other active ocular disease.
Exclusion Criteria
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may 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.
- No extended wear in the last 3 months.
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
- Employee or family member of the staff of the investigational site.
Data sourced from ClinicalTrials.gov (NCT01669629). 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.