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Completed

NCT Number: NCT02251561

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

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.

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Key information

Conditions

Corneal Staining

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FID 109182

Device

Investigational multipurpose contact lens cleaning and disinfecting solution

Other names: Opti-Free III

Opti-Free Plus

Device

Commercially available multipurpose contact lens cleaning and disinfecting solution

Other names: Opti-Free Plus®

Senofilcon A contact lens

Device

Commercially available silicone hydrogel contact lens

Other names: Acuvue® Oasys®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2014
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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