Prospective Study of an Investigational Daily Disposable Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01295905
First received: February 11, 2011
Last updated: June 26, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.


Condition Intervention
Myopia
Device: delefilcon A contact lens
Device: narafilcon B contact lens

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity [ Time Frame: 3 months of wear, lenses replaced daily ] [ Designated as safety issue: No ]
    Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.


Secondary Outcome Measures:
  • Overall Vision [ Time Frame: 3 months of wear, lenses replaced daily ] [ Designated as safety issue: No ]
    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

  • Overall Comfort [ Time Frame: 3 months of wear, lenses replaced daily ] [ Designated as safety issue: No ]
    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

  • Overall Handling [ Time Frame: 3 months of wear, lenses replaced daily ] [ Designated as safety issue: No ]
    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 90
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: delefilcon A
Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Device: delefilcon A contact lens
Investigational silicone hydrogel, single vision soft contact lens
Active Comparator: narafilcon B
Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Device: narafilcon B contact lens
Commercially marketed silicone hydrogel, single vision soft contact lens

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with normal eyes who are not using any ocular medications.
  • Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
  • Willing and able to wear spherical contact lenses for at least 5 days per week.
  • Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
  • Best spectacle-corrected visual acuity greater than or equal to 20/25.
  • Manifest cylinder less than or equal to 0.75D.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any active anterior segment ocular disease that would contraindicate contact lens wear.
  • Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
  • History of refractive surgery or irregular cornea.
  • History of pathologically dry eye.
  • Eye injury within twelve weeks immediately prior to enrollment for this trial.
  • Currently enrolled in any clinical trial.
  • Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01295905     History of Changes
Other Study ID Numbers: P-347-C-004
Study First Received: February 11, 2011
Results First Received: April 18, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014