Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00383201
First received: September 28, 2006
Last updated: August 15, 2012
Last verified: September 2006
  Purpose

To clinically evaluate the effect of a new multi-purpose disinfecting solution compared to a marketed multi-purpose solution on wettability of soft contact lenses worn for 30 days.


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: Long-Term Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles of Soft Contact Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Efficacy:
  • Contact lens wetting angle measured ex-vivo
  • Safety:
  • Slit-lamp Findings: Eyelids and Conjunctiva; Cornea; Iris, Anterior Chamber
  • Visual Acuity (Snellen)
  • Adverse Events

Estimated Enrollment: 80
Study Start Date: March 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • Successful daily wear of FDA Group I or IV soft contact lenses for at least one week.
  • 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.
  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: NCT00383201

Locations
United States, Texas
Fort Worth Site
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Leslie Napier Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00383201     History of Changes
Other Study ID Numbers: C-05-01
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 July 24, 2014