Skip to main content
OpenTrials
Completed

NCT Number: NCT01875471

Clinical Evaluation of Two Daily Disposable Contact Lenses

The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Knowle, Bristol, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

delefilcon A

Device

Daily disposable soft contact lens to be worn at least 8 hours daily

Other names: DAILIES Total 1

narafilcon A

Device

Daily disposable contact lens to be worn at least 8 hours daily

Other names: 1-Day ACUVUE TruEye

Primary outcomes

  1. Subjective Ease of Lens Removal

    Time frame: Day 7

    After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.