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

NCT02251561 | Completed Results

• 1 other identifier: CVKK2013-01
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Corneal Staining

Keywords

contact lenses; contact lens solution; corneal staining; fluorescein

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein

  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 Outcomes (1)

• Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein

  Day 1, after 2 hours of wear

Study Arms (2)

FID 109182

EXPERIMENTAL

Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours

Device: FID 109182; Device: Senofilcon A contact lens

Opti-Free Plus

ACTIVE COMPARATOR

Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours

Device: Opti-Free Plus; Device: Senofilcon A contact lens

Interventions

FID 109182 DEVICE

Investigational multipurpose contact lens cleaning and disinfecting solution

Also known as: Opti-Free III

FID 109182

Opti-Free Plus DEVICE

Commercially available multipurpose contact lens cleaning and disinfecting solution

Also known as: Opti-Free Plus®

Opti-Free Plus

Senofilcon A contact lens DEVICE

Commercially available silicone hydrogel contact lens

Also known as: Acuvue® Oasys®

FID 109182; Opti-Free Plus

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Soft contact lenses habitual wearer, both eyes.
• Voluntarily sign Informed Consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Results Point of Contact

• Title: Director, Clinical & Regulatory Affairs, Division of Medical Affairs
• Organization: Alcon Japan, Ltd.

alcon.medinfo@alcon.com

Study Officials

• Tsunemitsu Senta

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-06