Wettability of Contact Lenses With a Multi-Purpose Solution

August 18, 2014 updated by: Alcon Research
Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a Multi-Purpose Solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with normal eyes who have successfully worn contact lenses on a daily basis for at least two weeks prior to the study.
  • Must be wearing lenses a minimum of eight hours a day
  • Vision must be correctable to 20/30 (snellen) or better in each eye at a distance with soft contact lenses
  • Use no topical ocular OTC or prescribed ocular medication

Exclusion Criteria:

  • Subjects with current lid or conjunctival infections, abnormalities, inflammation, abnormal corneal opacities, significant lenticular inclusions, iritis, ocular disease or condition, corneal surgery, cataract surgery, intraocular lens implants, or glaucoma filtering surgery.
  • Subjects using systemic medications, upper respiratory infections or colds, history of seasonal allergies with significant ocular side effects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Polyquaternium-preserved Multi-purpose solution
Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182
Lens Cleaning Solution Formulation Identification Number 109182

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lens Wettability - ex-vivo wetting angle
Time Frame: From baseline
From baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Slit-lamp findings Corrected visual acuity (snellen) Adverse events
Time Frame: From baseline
From baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 11, 2008

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C-07-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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