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Clinical Evaluation of Two Daily Disposable Contact Lenses

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
delefilcon A
narafilcon A
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Refractive Error

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.
  2. 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).
  3. The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.
  4. The subject must be a current successful spherical soft contact lens wearer in both eyes.
  5. The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.
  6. 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.
  7. The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.
  8. The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.
  9. The subject must require a visual correction in both eyes (no monofit or monovision allowed).

Exclusion Criteria:

  1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  3. 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.
  4. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  5. Any ocular infection.
  6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  7. Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).
  8. Diabetes.
  9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
  10. Amblyopia
  11. Evidence of lid abnormality or infection (including blepharitis/meibomitis)
  12. Conjunctival abnormality or infection.
  13. Any active ocular disease.
  14. Employee or family member of the staff of the investigational site.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

delefilcon A

narafilcon A

Arm Description

Spherical daily disposable soft contact lens

Spherical daily disposable soft contact lens Class 1 UV blocking

Outcomes

Primary Outcome Measures

Subjective Ease of Lens Removal
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).

Secondary Outcome Measures

Full Information

First Posted
June 7, 2013
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01875471
Brief Title
Clinical Evaluation of Two Daily Disposable Contact Lenses
Official Title
Clinical Evaluation of Two Daily Disposable Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
delefilcon A
Arm Type
Active Comparator
Arm Description
Spherical daily disposable soft contact lens
Arm Title
narafilcon A
Arm Type
Experimental
Arm Description
Spherical daily disposable soft contact lens Class 1 UV blocking
Intervention Type
Device
Intervention Name(s)
delefilcon A
Other Intervention Name(s)
DAILIES Total 1
Intervention Description
Daily disposable soft contact lens to be worn at least 8 hours daily
Intervention Type
Device
Intervention Name(s)
narafilcon A
Other Intervention Name(s)
1-Day ACUVUE TruEye
Intervention Description
Daily disposable contact lens to be worn at least 8 hours daily
Primary Outcome Measure Information:
Title
Subjective Ease of Lens Removal
Description
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).
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
City
Knowle
State/Province
Bristol
ZIP/Postal Code
BS4 2AL
Country
United Kingdom
City
Portchester
State/Province
Hampshire
ZIP/Postal Code
PO16 9UN
Country
United Kingdom
City
Hay-on-Wye
State/Province
Herefordshire
ZIP/Postal Code
HR3 5EQ
Country
United Kingdom
City
St. Albans
State/Province
Herts
ZIP/Postal Code
AL1 3LH
Country
United Kingdom
City
Eastcote, Pinner
State/Province
Middlesex
ZIP/Postal Code
HA5 1RJ
Country
United Kingdom
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF24 3RQ
Country
United Kingdom
City
Farnham
State/Province
Surrey
ZIP/Postal Code
GU9 7EN
Country
United Kingdom
City
Brighton
ZIP/Postal Code
BN1 1RH
Country
United Kingdom
City
London
ZIP/Postal Code
N2 8AG
Country
United Kingdom
City
London
ZIP/Postal Code
NW4 3FB
Country
United Kingdom
City
Norwich
ZIP/Postal Code
NR2 1PB
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of Two Daily Disposable Contact Lenses

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