Mucinex® for Treatment of Filamentary Keratitis

Not Applicable

Completed

• Conditions: Filamentary Keratitis
• Interventions: Drug: Mucinex®

• Registration Number: NCT02859246
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-09
• Study Start: 2016-09
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Results First Submitted: 2019-11-07
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-07
• Last Update Submitted: 2020-02-07
• Results First Posted: 2020-02-19
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mucinex	Mucinex®	600 mg of Mucinex 2 times a day.

Primary Outcome Measures

Name	Time	Method
Change in Number of Corneal Filaments	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

Name	Time	Method
Change in OSDI Score	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.

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States