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Mucinex® for Treatment of Filamentary Keratitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Massachusetts Eye and Ear Infirmary
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT02859246
First received: August 4, 2016
Last updated: September 26, 2016
Last verified: September 2016
  Purpose
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 Intervention
Filamentary Keratitis
Drug: Mucinex®

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mucinex® for Treatment of Filamentary Keratitis

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Mucinex® for the treatment of filamentary keratitis [ Time Frame: 1 month ]
    Reduction of symptoms according to the ocular surface disease index score after treatment with oral Mucinex® twice a day for 4 weeks


Secondary Outcome Measures:
  • Mucinex® for the treatment of filamentary keratitis [ Time Frame: 1 month ]
    Reduction in the number of corneal filaments after treatment with oral Mucinex® twice a day for 4 weeks.


Estimated Enrollment: 15
Study Start Date: September 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mucinex
600 mg of Mucinex 2 times a day.
Drug: Mucinex®
Mucinex®

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02859246

Contacts
Contact: Ophthalmology Clinical Research 617-573-6060 opthalmologyclinicalresearch@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Vijeeta Tadla    617-573-6060    opthalmologyclinicalresearch@meei.harvard.edu   
Principal Investigator: Reza Dana, MD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Reza Dana, M.D, MPH, M.Sc Massachusetts Eye and Ear Infirmary
  More Information

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02859246     History of Changes
Other Study ID Numbers: 16-044H
Study First Received: August 4, 2016
Last Updated: September 26, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Keratitis
Corneal Diseases
Eye Diseases
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on March 23, 2017