The Effect of Punctal Plugs on Tear Volume and Osmolality

NCT ID: NCT00372034

Last Updated: 2009-04-07

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-03-31

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 role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.

Detailed Description

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

50% of contact lens wearers have dryness/discomfort during contact lens wear. Significant decreases in lipid layer and tear film break up time during contact lens wear have been reported, leading to excessive evaporation, reduced tear volume and an increase in osmolality.

Similar tear film changes occur with Dry Eye Disease. A commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms. Punctal plugs block the tear drainage system, and often increase tear stability, and improve ocular surface health.

This study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. Collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days) occlusion of the ocular drainage system, are easily removed if necessary and are inserted with minimal risk.

Conditions

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

Dry Eye Syndromes

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Temporary Collagen Inserts

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Over 18 years of age

Exclusion Criteria

* Corneal refractive surgery
* Contraindications to contact lens wear
* Latex allergy
* Corneal hypoesthesia
* Active corneal infection
* Acute or sub-acute inflammation or infection of the anterior chamber of the eye
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

The University of New South Wales

OTHER

Sponsor Role lead

Principal Investigators

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

Ulrike Stahl, Dipl-Optom

Role: PRINCIPAL_INVESTIGATOR

VisionCRC, School of Optometry and Vision Science, Institute for Eye Research

Locations

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

Vision CRC, Institute for Eye Research, School of Optometry and Vision Science

Sydney, New South Wales, Australia

Site Status

Countries

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

Australia

Other Identifiers

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

VRRP2005-018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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