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Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01240135
First received: November 10, 2010
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).


Condition Intervention
Contact Lens Fit
Myopia
 Device: FID 114675A multi-purpose disinfecting solution (MPDS)
Device: renu fresh Multi-Purpose Solution (MPS)
Device: Galyfilcon A contact lenses (Acuvue Advance)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Lens Fit [ Time Frame: Day 14 of lens wear ] [ Designated as safety issue: No ]
    As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.


Secondary Outcome Measures:
  • Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score [ Time Frame: Day 14 of lens wear ] [ Designated as safety issue: No ]
    The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.


Enrollment: 89
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
FID 114576A / renu fresh
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
 Device: FID 114675A multi-purpose disinfecting solution (MPDS)
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
Other Name: Alcon Multi-Purpose Disinfecting Solution (MPDS)
Device: renu fresh Multi-Purpose Solution (MPS)
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
Other Name: Bausch + Lomb renu® fresh™ Multi-Purpose Solution
Device: Galyfilcon A contact lenses (Acuvue Advance)
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
Other Name: Acuvue® Advance®
renu fresh / FID 114675A
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
 Device: FID 114675A multi-purpose disinfecting solution (MPDS)
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
Other Name: Alcon Multi-Purpose Disinfecting Solution (MPDS)
Device: renu fresh Multi-Purpose Solution (MPS)
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
Other Name: Bausch + Lomb renu® fresh™ Multi-Purpose Solution
Device: Galyfilcon A contact lenses (Acuvue Advance)
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
Other Name: Acuvue® Advance®

  Eligibility

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

Inclusion Criteria:

  • 18 years of age or older.
  • History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
  • Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
  • Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
  • History of intolerance or known sensitivity to any component of the treatments.
  • Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01240135     History of Changes
Other Study ID Numbers: C-10-030
Study First Received: November 10, 2010
Results First Received: June 8, 2012
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact Lens Wear
Contact Lens Solution
Multi-purpose disinfecting solution
Myopia

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Contact Lens Solutions
 Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013