Evaluation of an Investigational Multi-Purpose Solution (MPS)

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

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-11-30

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 evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens

NCT01294917

Normal Contact Lens Wearers

COMPLETED NA

Comfort and Cleaning Evaluation of Multipurpose Solutions in Contact Lens Patients

NCT00519948

Patient Comfort Lens Cleanliness

COMPLETED PHASE4

Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers

NCT00929487

Myopia

COMPLETED NA

Comfort Evaluation of a New MPS vs. Replenish in Contact Lens Patients

NCT00518700

Corneal Staining

COMPLETED PHASE4

Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

NCT01024855

Myopia Hyperopia Astigmatism

COMPLETED PHASE1/PHASE2

Detailed Description

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

A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.

Conditions

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

Study Focus is Healthy Contact Lens Wearers

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Investigational MPS

Investigational multipurpose disinfecting solution (study MPS)

Group Type EXPERIMENTAL

Investigational MPS

Intervention Type DEVICE

Multi-purpose solution

Predicate MPS

Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)

Group Type ACTIVE_COMPARATOR

Opti-Free

Intervention Type DEVICE

Multi-purpose solution

Interventions

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

Investigational MPS

Multi-purpose solution

Intervention Type DEVICE

Opti-Free

Multi-purpose solution

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cobra RepleniSH

Eligibility Criteria

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

Inclusion Criteria

* Have successfully worn hydrogel contact lenses of the same material to be worn during the study
* Have normal eyes (with the exception of unaided visual acuity)
* Have successfully used a multi-purpose contact lens care solution
* Have acceptable visual acuity and lens wearing comfort at time of enrollment

Exclusion Criteria

* Concurrently enrolled another clinical trial
* Have a known sensitivity to any study product ingredient(s)
* Have a condition that may put them at significant risk

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes