Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan

June 3, 2015 updated by: Alcon Research

Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®

The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Soft contact lenses habitual wearer, both eyes.
  • Voluntarily sign Informed Consent.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.
  • Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.
  • Eye infection, blepharitis, iris inflammation, or severe eye inflammation.
  • Corneal staining greater than Grade 1 at baseline.
  • Pregnant, lactating, or intend to become pregnant during study period.
  • Other protocol-defined exclusion criteria may apply.

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

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FID 109182
Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours
Device: FID 109182
Investigational multipurpose contact lens cleaning and disinfecting solution
Other Names:
  • Opti-Free III
Device: Senofilcon A contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • Acuvue® Oasys®
Active Comparator: Opti-Free Plus
Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours
Device: Senofilcon A contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • Acuvue® Oasys®
Device: Opti-Free Plus
Commercially available multipurpose contact lens cleaning and disinfecting solution
Other Names:
  • Opti-Free Plus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
Time Frame: Day 1, after 2 hours of wear
The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.
Day 1, after 2 hours of wear

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein
Time Frame: Day 1, after 2 hours of wear
The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.
Day 1, after 2 hours of wear

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Tsunemitsu Senta, Alcon Japan, Ltd.

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

November 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CVKK2013-01

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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