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The Clinical Evaluation of Two Daily Disposable Contact Lenses

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ClinicalTrials.gov Identifier: NCT00762996
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : June 23, 2009
Last Update Posted : May 21, 2015
Sponsor:
Collaborator:
Eurolens Research
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Condition or disease Intervention/treatment Phase
Myopia Device: etafilcon A Device: omafilcon A Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: etafilcon A/etafilcon A
Period 1: etafilcon A, Period 2: etafilcon A
Device: etafilcon A
contact lens
Active Comparator: etafilcon A/omafilcon A
Period 1: etafilcon A, Period 2: omafilcon A
Device: etafilcon A
contact lens
Device: omafilcon A
contact lens
Active Comparator: omafilcon A/etafilcon A
Period 1: omafilcon A, Period 2: etafilcon A
Device: etafilcon A
contact lens
Device: omafilcon A
contact lens
Active Comparator: omafilcon A/omafilcon A
Period 1: omafilcon A, Period 2: omafilcon A
Device: omafilcon A
contact lens



Primary Outcome Measures :
  1. Distance Visual Acuity [ Time Frame: 1 week ]
    logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.


Secondary Outcome Measures :
  1. Lens Comfort [ Time Frame: 1 week ]
    A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • They are of legal age (18 years) and capacity to volunteer.
  • They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
  • They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
  • They have a maximum of 1.00D of refractive astigmatism (i.e. < 1.00 DC).
  • They have worn soft contact lenses within six months of starting the study.

Exclusion Criteria:

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  • They are pregnant or lactating.
  • They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  • They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
  • They have diabetes.
  • They are currently taking part in any other clinical study or research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762996


Locations
United Kingdom
Eurolens Research
Manchester, United Kingdom, M60 1QD
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Eurolens Research

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00762996     History of Changes
Other Study ID Numbers: CR-0707
First Posted: September 30, 2008    Key Record Dates
Results First Posted: June 23, 2009
Last Update Posted: May 21, 2015
Last Verified: May 2015