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
About this trial
This is an interventional treatment trial for Filamentary Keratitis
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.
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
NCT ID
NCT02859246
First Posted
August 4, 2016
Last Updated
February 7, 2020
Sponsor
Massachusetts Eye and Ear Infirmary
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
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