The Clinical Evaluation of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Collaborator:
Eurolens Research
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00762996
First received: September 26, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Myopia
Device: etafilcon A
Device: omafilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Distance Visual Acuity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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:
  • Lens Comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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


Enrollment: 65
Study Start Date: August 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762996

Locations
United Kingdom
Eurolens Research
Manchester, United Kingdom, M60 1QD
Sponsors and Collaborators
Vistakon
Eurolens Research
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00762996     History of Changes
Other Study ID Numbers: CR-0707
Study First Received: September 26, 2008
Results First Received: October 24, 2008
Last Updated: December 17, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014