search
Back to results

Mucinex® for Treatment of Filamentary Keratitis

Primary Purpose

Filamentary Keratitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mucinex®
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Filamentary Keratitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Mucinex

Arm Description

600 mg of Mucinex 2 times a day.

Outcomes

Primary Outcome Measures

Change in Number of Corneal Filaments
Change was calculated as the value after receiving treatment with guaifenesin for 4 weeks minus the value at baseline.

Secondary Outcome Measures

Change in OSDI Score
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.

Full Information

First Posted
August 4, 2016
Last Updated
February 7, 2020
Sponsor
Massachusetts Eye and Ear Infirmary
search

1. Study Identification

Unique Protocol Identification Number
NCT02859246
Brief Title
Mucinex® for Treatment of Filamentary Keratitis
Official Title
Mucinex® for Treatment of Filamentary Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Filamentary Keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mucinex
Arm Type
Other
Arm Description
600 mg of Mucinex 2 times a day.
Intervention Type
Drug
Intervention Name(s)
Mucinex®
Other Intervention Name(s)
Guaifenesin
Intervention Description
Mucinex®
Primary Outcome Measure Information:
Title
Change in Number of Corneal Filaments
Description
Change was calculated as the value after receiving treatment with guaifenesin for 4 weeks minus the value at baseline.
Time Frame
baseline (day 1) and week 4
Secondary Outcome Measure Information:
Title
Change in OSDI Score
Description
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.
Time Frame
baseline (day 1) and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Dana, M.D,MPH,M.Sc
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://doi.org/10.1016/j.jtos.2019.03.008
Description
Related Info

Learn more about this trial

Mucinex® for Treatment of Filamentary Keratitis

We'll reach out to this number within 24 hrs