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Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00382603
First received: September 28, 2006
Last updated: August 15, 2012
Last verified: September 2006
History of Changes
  Purpose

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.


Condition Intervention
Contact Lens Care
 Device: OptiFree Multi-Purpose Disinfecting Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients

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:
  • Efficacy:
  • Ocular Comfort and Symptom Scales
  • Subject Questions/Subject Likert Questionnaire
  • Safety:
  • Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
  • Adverse Events

Secondary Outcome Measures:
  • Corneal Fluorescein Staining (Type and Area)
  • Lens Surface Evaluation (Lens Deposit and Lens Wettability)
  • Lens Replacement Incidence and Causality
  • Corrected Visual Acuity with Study Lenses (Snellen)
  • Rewetting Drop Frequency
  • Lens Removal Frequency
  • Average Lens Wearing Time
  • Average Uncomfortable Lens Wearing Time

Estimated Enrollment: 362
Study Start Date: August 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Symptomatic for contact lens related discomfort at the end of the lens wearing day.
  • Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
  • Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
  • Successful lens wear for at least 4 hours per day.
  • Vision correctable to 20/30.
  • Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
  • No corneal surgery within the past 12 months.
  • No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
  • No over-the-counter or prescription ocular medication.
  • No enrollment in another clinical study within 30 days prior to enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382603

Locations
United States, Colorado
Highlands Ranch
Highlands Ranch, Colorado, United States, 80126
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Leslie Napier Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00382603     History of Changes
Other Study ID Numbers: C-04-09
Study First Received: September 28, 2006
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact Lens Care

ClinicalTrials.gov processed this record on May 23, 2013