Mucinex® for Treatment of Filamentary Keratitis

February 7, 2020 updated by: Reza Dana, MD, Massachusetts Eye and Ear Infirmary
It is a pilot study aimed to determine if oral Mucinex® is effective in reducing the amount of corneal filaments and improving symptomology in subjects with filamentary keratitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is aimed to determine if oral administration of Mucinex® is effective in reducing the amount of corneal filaments and improving symptomology in subjects with filamentary keratitis. Subjects will be instructed to take 600 mg tablets of extended release Mucinex® twice a day (total dose is 1.2 g/day) for 4 weeks.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with filamentary keratitis
  • 18 years and older

Exclusion Criteria:

  • Active ocular surface infection of any type
  • Recent ocular surgery (<30 days) history of nephrolithiasis as Mucinex® has been associated in rare cases of development of kidney stones
  • Schirmer's test<3mm
  • History of hypersensitivity to Mucinex®
  • Concurrent eye disease requiring immediate initiation of a new treatment (e.g. topical steroids) restriction for water intake can exacerbate the risk of nephrolithiasis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mucinex
600 mg of Mucinex 2 times a day.
Drug: Mucinex®
Mucinex®
Other Names:
  • Guaifenesin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Number of Corneal Filaments
Time Frame: baseline (day 1) and week 4
Change was calculated as the value after receiving treatment with guaifenesin for 4 weeks minus the value at baseline.
baseline (day 1) and week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in OSDI Score
Time Frame: baseline (day 1) and week 4

Change was calculated as the value after receiving treatment with guaifenesin for 4 weeks minus the value at baseline.

Total score ranges from 0-100. Lower OSDI scores means subjects are experiencing low ocular discomfort. High OSDI scores means subjects are experiencing high ocular discomfort.
baseline (day 1) and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Eye and Ear Infirmary

Investigators

  • Principal Investigator: Reza Dana, M.D,MPH,M.Sc, Massachusetts Eye and Ear Infirmary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-044H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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