Mucinex® for Treatment of Filamentary Keratitis

NCT ID: NCT02859246

Last Updated: 2020-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Filamentary Keratitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mucinex

600 mg of Mucinex 2 times a day.

Group Type OTHER

Mucinex®

Intervention Type DRUG

Mucinex®

Interventions

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Mucinex®

Mucinex®

Intervention Type DRUG

Other Intervention Names

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Guaifenesin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Reza Dana, MD

Reza Dana, MD, MPH, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reza Dana, M.D,MPH,M.Sc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Locations

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Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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16-044H

Identifier Type: -

Identifier Source: org_study_id

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