A Comparison of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00600080
First received: December 21, 2007
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.


Condition Intervention
Myopia
Device: etafilcon A
Device: nelfilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 2-week ] [ Designated as safety issue: No ]
    Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.

  • Subjective Lens Comfort [ Time Frame: 2-week ] [ Designated as safety issue: No ]
    Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.


Secondary Outcome Measures:
  • Subject-reported Overall Product Performance [ Time Frame: 2-week ] [ Designated as safety issue: No ]
    Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.

  • Optimum Lens Fit [ Time Frame: Baseline, 1-week, 2-week ] [ Designated as safety issue: No ]
    Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.


Enrollment: 60
Study Start Date: December 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
etafilcon A first nelfilcon A second
etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2
Device: etafilcon A
contact lens worn daily for one week (first or second week depending on arm)
Other Name: 1-DAY ACUVUE MOIST
Device: nelfilcon A
Contact lens worn daily for one week (first or second week depending on arm)
Other Name: DAILIES AquaComfort Plus
nelfilcon A first, etafilcon A second
nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2
Device: etafilcon A
contact lens worn daily for one week (first or second week depending on arm)
Other Name: 1-DAY ACUVUE MOIST
Device: nelfilcon A
Contact lens worn daily for one week (first or second week depending on arm)
Other Name: DAILIES AquaComfort Plus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. They are of legal age (18 years) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
  5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
  6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
  7. They have successfully worn contact lenses within six months of starting the study. -

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They are aphakic.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  7. They are pregnant or lactating.
  8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
  10. They have diabetes.
  11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
  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: NCT00600080

Locations
United Kingdom
Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
Manchester, United Kingdom, M60 1QD
Sponsors and Collaborators
Vistakon
University of Manchester
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00600080     History of Changes
Other Study ID Numbers: CR-0729
Study First Received: December 21, 2007
Results First Received: October 20, 2011
Last Updated: February 6, 2014
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