Mucinex® for Treatment of Filamentary Keratitis

NCT02859246 | Completed Results

• 1 other identifier: 16-044H
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Filamentary Keratitis

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline (day 1) and week 4

Secondary Outcomes (1)

• Change in OSDI Score

  baseline (day 1) and week 4

Study Arms (1)

Mucinex

OTHER

600 mg of Mucinex 2 times a day.

Drug: Mucinex®

Interventions

Mucinex® DRUG

Mucinex®

Also known as: Guaifenesin

Mucinex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with filamentary keratitis
• years and older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Acetylcysteine; Guaifenesin

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Reza Dana
• Organization: Massachusetts Eye and Ear Infirmary

Reza_Dana@meei.harvard.edu

617-573-4331

Study Officials

• Reza Dana, M.D,MPH,M.Sc

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reza Dana, MD, MPH, MSc

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 9, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)