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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
  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:


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
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
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:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014