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Mucinex® for Treatment of Filamentary Keratitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02859246
Recruitment Status : Completed
First Posted : August 9, 2016
Results First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye and Ear Infirmary

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.

Condition or disease Intervention/treatment Phase
Filamentary Keratitis Drug: Mucinex® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mucinex® for Treatment of Filamentary Keratitis
Actual Study Start Date : September 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Mucinex
600 mg of Mucinex 2 times a day.
Drug: Mucinex®
Mucinex®
Other Name: Guaifenesin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859246


Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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Principal Investigator: Reza Dana, M.D,MPH,M.Sc Massachusetts Eye and Ear Infirmary
  Study Documents (Full-Text)

Documents provided by Reza Dana, MD, Massachusetts Eye and Ear Infirmary:
Study Protocol  [PDF] October 20, 2016
Statistical Analysis Plan  [PDF] July 21, 2019

Additional Information:
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Responsible Party: Reza Dana, MD, Reza Dana, MD, MPH, MSc, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02859246    
Other Study ID Numbers: 16-044H
First Posted: August 9, 2016    Key Record Dates
Results First Posted: February 19, 2020
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Keratitis
Corneal Diseases
Eye Diseases
Guaifenesin
Expectorants
Respiratory System Agents