Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Clinical Evaluation of Two Daily Disposable Contact Lenses

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Conditions:

Refractive Error

Eligibility:

All Genders

18-45 years

Phase:

NA

Brief 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

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2013

Estimated Enrollment :

279 Patients enrolled

Trial Details

Trial ID

NCT01875471

Start Date

June 1 2013

End Date

August 1 2013

Last Update

June 19 2018

Active Locations (11)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (11 locations)

1

Knowle, Bristol, United Kingdom, BS4 2AL

2

Portchester, Hampshire, United Kingdom, PO16 9UN

3

Hay-on-wye, Herefordshire, United Kingdom, HR3 5EQ

4

St Albans, Herts, United Kingdom, AL1 3LH