Studying the Relationship Between Contact Lens Packaging Solutions and Bacterial Binding to Surface Eye Cells

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-08-31

Brief Summary

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

The goal of this study is to investigate the overall theory that the use of chemically preserved solutions associated with contact lenses promotes an increase in bacterial infection.

Related Clinical Trials

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

Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials

NCT04108286

Visual Acuity

WITHDRAWN NA

A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

NCT01449526

Myopia

COMPLETED NA

Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

NCT02258139

Corneal Deformity

COMPLETED NA

A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution

NCT02701556

Contact Lens Wear

COMPLETED NA

Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes

NCT02806921

Keratoconus

COMPLETED NA

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 investigate the theory of bacterial binding to surface eye cells through the use of chemically preserved solutions.

Conditions

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

Corneal Ulcer

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

SINGLE

Participants

Study Groups

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

Contact Lens Packaging Solution #1

Test solution - contact lens packaging solution

Group Type EXPERIMENTAL

Contact lens packaging solution

Intervention Type DEVICE

These test solutions are the intervention being tested.

Contact lens packaging solution #2

Test solution - contact lens packaging solution

Group Type EXPERIMENTAL

Contact lens packaging solution

Intervention Type DEVICE

These test solutions are the intervention being tested.

Balanced salt solution

Control solution

Group Type PLACEBO_COMPARATOR

Balanced salt solution (BSS)

Intervention Type DEVICE

BSS is isotonic to the tissues of the eyes.

Interventions

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

Contact lens packaging solution

These test solutions are the intervention being tested.

Intervention Type DEVICE

Balanced salt solution (BSS)

BSS is isotonic to the tissues of the eyes.

Intervention Type DEVICE

Other Intervention Names

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

Blister pack solution Saline solution

Eligibility Criteria

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

Inclusion Criteria

* Age range: 18-38 years
* Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged.
* No prior history of any contact lens wear within one month of entry into the study.
* No history of allergic eye disease either seasonal or associated with previous contact lens wear.

Exclusion Criteria

* Any patient that is a current contact lens wearer.
* Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, glaucoma, etc.
* Uncontrolled systemic disease or the presence of any significant illness or condition that could, in the judgment of the investigator, interfere with interpretation of the study results.
* Any patient using ocular tears, anti-histamine based ocular therapies, glaucoma therapy, vasoconstricting drops, etc.

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes