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N/A N=275 Randomized Single-blind Other

Clinical Evaluation of Two Daily Disposable Contact Lenses

Refractive Error

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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