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

Not Applicable

Completed

• Conditions: Corneal Staining
• Interventions: Device: Opti-Free Plus; Device: FID 109182; Device: Senofilcon A contact lens

• Registration Number: NCT02251561
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-29
• Results First Submitted: 2015-05-20
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-03
• Last Update Submitted: 2015-06-03
• Results First Posted: 2015-06-10
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FID 109182	Senofilcon A contact lens	Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours
Opti-Free Plus	Opti-Free Plus	Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours
Opti-Free Plus	Senofilcon A contact lens	Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours
FID 109182	FID 109182	Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein	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.