NCT01341977

Completed

Safety and Efficacy of an Investigational Multi-Purpose Disi...

Alcon Research Source

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Other study identifiers

Sponsor study identifier

C-09-026

Study Type

interventional

Actual enrollment (reported)

573

Locations

1 country

Sites

1

Timeline

Study Start

November 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

Brief Summary

The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Registry Overview

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

Recruitment status: completed
Actual enrollment (reported): 573 participants
Study completion date: May 2010
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
November 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 9, 2009
Actual (reported)
Primary Completion
May 2010
Actual (reported)
Study Completion
May 2010
Actual (reported)
First Posted
April 26, 2011
Actual (reported)
Results Posted
October 13, 2011
Actual (reported)

Last Updated: September 23, 2020
Status Verified: September 2011
Results QC Date: September 8, 2011
Last Update Submitted: September 1, 2020

Conditions

Healthy Contact Lens Wearers

Keywords

Contact LensesContact Lens CareMulti-Purpose Solution

Outcome Measures

Primary Outcomes (1)

Subjective Acceptance
Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)
Day 90

Study Arms (2)

Alcon MPDS

EXPERIMENTAL

Alcon Multi-Purpose Disinfecting Solution (MPDS)

Device: Alcon MPDS

ReNu Fresh Multi-Purpose Solution

ACTIVE COMPARATOR

ReNu Fresh Multi-Purpose Solution

Device: ReNu Fresh MPS

Interventions

Alcon MPDSDevice

Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses

Also known as: Alcon Multi-Purpose Disinfecting Solution (MPDS)

Alcon MPDS

ReNu Fresh MPSDevice

ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses.

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
Patient must be able to read.

Sponsors & Collaborators

Alcon Research
Industrylead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Results Point of Contact

Title: Alcon Clinical
Organization: Alcon Research, Ltd.

Study Officials

Jessie M Lemp, MS
Alcon Research
STUDY DIRECTOR

Publication Agreements

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

Enrollment

573 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 9, 2009

First Posted

April 26, 2011

Study Start

November 2009

Date type not reported

This date has not been verified as actual or estimated.

Also known as: ReNu Fresh Multi-Purpose Solution (MPS)

ReNu Fresh Multi-Purpose Solution

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

Vision correctable to 20/30 or better with contact lenses.

You may not qualify if:

Sensitivity to multi-purpose solutions.
Using any topical ocular OTC or prescribed topical ocular medications.
History or current ocular infections or ocular inflammatory events.
Ocular surgery within the past year.
With a medical condition or using medications that cause ocular side effects.
Participation in any investigational study within the past 30 days.

Contact the study team to confirm eligibility.

Primary Completion

May 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

Last Updated

September 23, 2020

Results First Posted

October 13, 2011

Record last verified: 2011-09

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: NCT01341977
Data provider: ClinicalTrials.gov
Source updated: 2020-09-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:54 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Alcon MPDS

ReNu Fresh Multi-Purpose Solution

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations