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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02251561
Other study ID # CVKK2013-01
Secondary ID
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-FreeĀ® 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


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
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