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Clinical Validation of the New Print on Focus DAILIES Toric

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01097863
First received: March 31, 2010
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to validate the improvements to the inversion indicator.


Condition Intervention
Myopia
Device: nelfilcon A contact lens, modified inversion indicator
Device: nelfilcon A contact lens, no inversion indicator
Device: nelfilcon A contact lens, inversion indicator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.


Enrollment: 280
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nelfilcon A, modified inversion indicator
Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
Device: nelfilcon A contact lens, modified inversion indicator
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
Experimental: nelfilcon A, no inversion indicator
Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
Device: nelfilcon A contact lens, no inversion indicator
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
Active Comparator: nelfilcon A, inversion indicator
Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
Device: nelfilcon A contact lens, inversion indicator
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator
Other Name: Focus DAILIES Toric

Detailed Description:

This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

  Eligibility

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

Inclusion Criteria:

  • Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
  • Willing and able to wear study lenses in both eyes in the available parameters.
  • Light-eyed subjects.
  • Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
  • Optimal or acceptable fit in each eye at time of dispensing.
  • Willing to wear the study lenses at least 8 hours a day, 5 days a week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment for this trial.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • RGP contact lens wearer.
  • 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: NCT01097863     History of Changes
Other Study ID Numbers: P-346-C-010
Study First Received: March 31, 2010
Results First Received: May 27, 2011
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014