Mode
Text Size
Log in / Sign up
N/A N=100 Randomized Treatment

Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

Refractive Ametropia

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire — 54.06; 53.06 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
etafilcon A with print and PVP for dark eyes (EAPVPDE) (Device); etafilcon A control lens (EADE) (Device)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Feb 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
54.06; 53.06
PRIMARY
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
53.61; 48.91
PRIMARY
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
61.21; 51.77

Summary

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Eligibility Criteria

Inclusion Criteria

  • The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
  • The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
  • The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
  • The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
  • The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
  • The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
  • Any cylinder power must be:<=0.75D.
  • The subject must have visual acuity best correctable to 20/25 or better for each eye.
  • The subject must have normal eyes (no ocular medications or ocular infection of any type).
  • 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, autoimmune disease, or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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.
  • Any color deficiencies (color blindness) - to the best of the subject's knowledge.
  • 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.
  • Subject presents with one dark iris color and one light iris color
  • Subject has heterochromia iridis (a difference in color between parts of one iris)
  • The subject is an employee or family member of the clinical study site.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01484054). 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.

Back to search