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
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.

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

ClinicalTrials.gov processed this record on September 29, 2014