N/A
N=275
Clinical Evaluation of Two Daily Disposable Contact Lenses
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01875471 ↗Enrolled (actual)
275
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Subjective Ease of Lens Removal — 45; 76; 23; 34 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- delefilcon A (Device); narafilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Ease of Lens Removal |
45; 76; 23; 34; 24; 10 | — |
Summary
The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.
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, at least 6 days between visits.
- The subject must be a current successful spherical soft contact lens wearer in both eyes.
- The subject must appear willing and able 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 (inclusive) in each eye.
- The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.
- The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.
- The subject must require a visual correction in both eyes (no monofit or monovision allowed).
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 infiltrates 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.
- Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
- Amblyopia
- Evidence of lid abnormality or infection (including blepharitis/meibomitis)
- Conjunctival abnormality or infection.
- Any active ocular disease.
- Employee or family member of the staff of the investigational site.
Data sourced from ClinicalTrials.gov (NCT01875471). 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.