Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

NCT ID: NCT00754338

Last Updated: 2023-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ametropia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase1 - Arm 1

Group Type ACTIVE_COMPARATOR

Alcon Opti-Free® RepleniSH® with Supraclens®

Intervention Type DRUG

Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover

Alcon Opti-Free® RepleniSH®

Intervention Type DRUG

Marketed Multipurpose Disinfecting Care System

Phase1 - Arm 2

Group Type ACTIVE_COMPARATOR

Alcon Opti-Free® RepleniSH® with Supraclens®

Intervention Type DRUG

Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover

Alcon Opti-Free® RepleniSH®

Intervention Type DRUG

Marketed Multipurpose Disinfecting Care System

Phase 2 - Arm 1

Group Type ACTIVE_COMPARATOR

Alcon Opti-Free® RepleniSH® with Supraclens®

Intervention Type DRUG

Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover

B&L ReNu MultiPlus™

Intervention Type DRUG

Marketed Multipurpose Disinfecting Care Systems

Phase 2 - Arm 2

Group Type ACTIVE_COMPARATOR

Alcon Opti-Free® RepleniSH® with Supraclens®

Intervention Type DRUG

Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover

B&L ReNu MultiPlus™

Intervention Type DRUG

Marketed Multipurpose Disinfecting Care Systems

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alcon Opti-Free® RepleniSH® with Supraclens®

Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover

Intervention Type DRUG

Alcon Opti-Free® RepleniSH®

Marketed Multipurpose Disinfecting Care System

Intervention Type DRUG

B&L ReNu MultiPlus™

Marketed Multipurpose Disinfecting Care Systems

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Is at least 17 years of age and has full legal capacity to volunteer.
* Has read, understood and signed an information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
* Has clear corneas and no active ocular disease.
* Has had an ocular examination in the last two years.
* Is a current soft lens wearer, replacing their lenses every two weeks to one month.
* Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
* Has astigmatism less than or equal to -1.00 DC.

Exclusion Criteria

* Has any signs or symptoms of dry eye.
* Has any clinically significant blepharitis.
* Has undergone corneal refractive surgery.
* Is aphakic.
* Has any active ocular disease.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that may affect ocular health.
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
* Is pregnant or lactating.
* Is participating in any other type of clinical or research study.
* Currently wears daily disposable lenses.
* Currently wears lenses on an extended wear basis.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role collaborator

University of Waterloo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Centre for Contact Lens Research

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Desmond Fonn, MOptom

Role: STUDY_CHAIR

University of Waterloo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Contact Lens Research, School of Optometry, University of Waterloo.

Waterloo, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P/279/07/L

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.