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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014