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

Corneal Staining Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251561
• Other study ID #: CVKK2013-01
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: June 3, 2015
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Corneal Staining

Intervention

Device:
• FID 109182
Investigational multipurpose contact lens cleaning and disinfecting solution
• Opti-Free Plus
Commercially available multipurpose contact lens cleaning and disinfecting solution
• Senofilcon A contact lens
Commercially available silicone hydrogel contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of Participants Scoring = 2 for Corneal Staining Area 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 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	No