Trials Sponsors Conditions Drugs Pricing

Conditions

Corneal Staining

Keywords

contact lensescontact lens solutioncorneal stainingfluorescein

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 109182Device: 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 PlusDevice: Senofilcon A contact lens

Interventions

FID 109182Device

Investigational multipurpose contact lens cleaning and disinfecting solution

Also known as: Opti-Free III

FID 109182

Opti-Free PlusDevice

Commercially available multipurpose contact lens cleaning and disinfecting solution

Also known as:

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Alcon Research
Industrylead

Results Point of Contact

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

Study Officials

Tsunemitsu Senta
Alcon Japan, Ltd.
STUDY DIRECTOR

Publication Agreements

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

Enrollment

36 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

FID 109182

Opti-Free Plus

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

FID 109182

Opti-Free Plus

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record