NCT00382603

Completed

Evaluation of an Investigational Multi-Purpose Disinfecting ...

Alcon Research Source

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Other study identifiers

Sponsor study identifier

C-04-09

Study Type

interventional

Reported enrollment (type unavailable)

362

Locations

1 country

Sites

1

Timeline

Study Start

August 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2005

Actual (reported)

Study Completion

February 2005

Actual (reported)

Brief Summary

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 362 participants
Study completion date: February 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
February 2005
Actual (reported)
Study Completion
February 2005
Actual (reported)
First Submitted
September 28, 2006
Actual (reported)
First Posted
September 29, 2006
Actual (reported)

Last Updated: August 16, 2012
Status Verified: September 2006
Last Update Submitted: August 15, 2012

Conditions

Contact Lens Care

Keywords

Contact Lens Care

Outcome Measures

Primary Outcomes (6)

Efficacy:
Ocular Comfort and Symptom Scales
Subject Questions/Subject Likert Questionnaire
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events

Secondary Outcomes (8)

Corneal Fluorescein Staining (Type and Area)
Lens Surface Evaluation (Lens Deposit and Lens Wettability)
Lens Replacement Incidence and Causality
Corrected Visual Acuity with Study Lenses (Snellen)
Rewetting Drop Frequency
+3 more secondary outcomes

Interventions

OptiFree Multi-Purpose Disinfecting SolutionDevice

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Symptomatic for contact lens related discomfort at the end of the lens wearing day.
Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.

Sponsors & Collaborators

Alcon Research
Industrylead

Study Sites (1)

Highlands Ranch

Highlands Ranch, Colorado, 80126, United States

Study Officials

Leslie Napier
Alcon Research
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

August 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2005

Actual (reported)

Completed

NCT06588400

AOSEPT (CLEAR CARE) PLUS Study

Not ApplicableWithdrawn

NCT06592521

OPTI-FREE Family STUDY

Not ApplicableWithdrawn

NCT00884806

7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers

Not ApplicableCompleted

NCT00407238

Corneal Barrier Function With Multi-Purpose Solutions

Not ApplicableCompleted

NCT01494818

Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

Not ApplicableCompleted

Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).

Successful lens wear for at least 4 hours per day.

Vision correctable to 20/30.

Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.

No corneal surgery within the past 12 months.

No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.

No over-the-counter or prescription ocular medication.

No enrollment in another clinical study within 30 days prior to enrollment.

Contact the study team to confirm eligibility.

Study Completion

February 2005

Actual (reported)

Last Updated

August 16, 2012

Record last verified: 2006-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00382603
Data provider: ClinicalTrials.gov
Source updated: 2012-08-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:47 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (8)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Source record

Locations