Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01996709
First received: November 18, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.


Condition Intervention
Refractive Error
Device: Hydrogen peroxide-based contact lens cleaning & disinfecting solution
Device: Biguanide-preserved contact lens MPS
Device: Subject's habitual contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change from baseline in investigator rated lid papillae maximum score at Day 90. [ Time Frame: Baseline (Day 0), Day 90 ] [ Designated as safety issue: No ]
    Lid Papillae (palpebral roughness) will be assessed by the investigator using slit-lamp biomicroscopy. Papillae will be classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a scale from 0-4, where 0=None and 4=Severe (giant papillae). The maximum of the four zones will be selected for the analysis.


Secondary Outcome Measures:
  • Top 2 box percentage agreement for "My lenses feel like new lenses" at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale will be used, where 1=strongly disagree, 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) will be calculated and reported as a percentage of all responses.

  • Mean frequency score for symptoms of grittiness at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    As reported and interpreted by the subject on a questionnaire. The subject will be asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and will respond on a 5-point scale (1=Never and 5=Constantly).

  • Mean frequency score for symptoms of end of day dryness at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    As reported and interpreted by the subject on a questionnaire. The subject will be asked for an end-of-day response, "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and will respond on a 5-point scale (0=Never and 4=Constantly).


Enrollment: 142
Study Start Date: December 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clear Care®
Hydrogen peroxide-based contact lens cleaning & disinfecting solution, used for disinfection and storage of subject's habitual contact lenses for 90 days.
Device: Hydrogen peroxide-based contact lens cleaning & disinfecting solution
Other Name: Clear Care®
Device: Subject's habitual contact lenses
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
Active Comparator: Multi-purpose solution (MPS)
Biguanide-preserved contact lens MPS per subject's habitual use, used for disinfection and storage of subject's habitual contact lenses for 90 days.
Device: Biguanide-preserved contact lens MPS Device: Subject's habitual contact lenses
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

  Eligibility

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

Inclusion Criteria:

  • Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
  • Vision correctable to 20/30 Snellen (feet) or better in each eye at distance.
  • Willing to wear study lenses on a daily wear schedule for at least 5 days a week and a minimum of 6 hours on these days, and attend all study visits.
  • Symptoms of contact lens discomfort as defined by the protocol.
  • Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
  • Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Extended (over-night) contact lens wearer.
  • Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
  • History of ocular surgery/trauma within the last 6 months.
  • Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
  • Systemic medications which have known or expected ocular or systemic side effects (i.e., antihistamines, dermatologic agents, or antidepressants), that in the clinical judgment of the Investigator, could affect the subject's participation in this study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1.
  • Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
  • Use of rewetting drops during the study other than Bausch and Lomb Sensitive Eyes® Rewetting Drops.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Other protocol-specified 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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996709

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Lisa Zoota, MPH Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01996709     History of Changes
Other Study ID Numbers: A01337
Study First Received: November 18, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Silicone hydrogel contact lenses
Multi-purpose solution
Lid Papillae
Palpebral Roughness

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014