Mucinex® for Treatment of Filamentary Keratitis

• Sponsor: Massachusetts Eye and Ear Infirmary (Other)
• Overall Status: Completed
• CT.gov ID: NCT02859246
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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®	N/A

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 Design

• Study Type: Interventional
• 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: Sep 1, 2016
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Mucinex 600 mg of Mucinex 2 times a day.	Drug: Mucinex®; Mucinex®; Other Names: Guaifenesin

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts Eye and Ear Infirmary

Investigators

• Principal Investigator: Reza Dana, M.D,MPH,M.Sc, Massachusetts Eye and Ear Infirmary

Study Documents (Full-Text)

• Study Protocol - Oct 20, 2016
• Statistical Analysis Plan - Jul 21, 2019

More Information

Additional Information:

• Related Info

Publications

None provided.

• 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: Aug 9, 2016
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Keratitis; Guaifenesin

Study Results

Participant Flow

Arm/Group Title	Mucinex
Arm/Group Description	600 mg of Mucinex 2 times a day. Mucinex®: Mucinex®
Period Title: Overall Study
STARTED	15
COMPLETED	10
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Mucinex
Arm/Group Description	600 mg of Mucinex 2 times a day. Mucinex®: Mucinex®
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 50%
>=65 years	6 50%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63.7
Sex: Female, Male (Count of Participants)
Female	5 41.7%
Male	7 58.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	12 100%
Number of Corneal Filaments in both eyes (number of corneal filaments) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of corneal filaments]	2.1 (2.2)

Outcome Measures

1. Primary Outcome

Title	Change in Number of Corneal Filaments
Description	Change was calculated as the value after receiving treatment with guaifenesin for 4 weeks minus the value at baseline.
Time Frame	baseline (day 1) and week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mucinex
Arm/Group Description	600 mg of Mucinex 2 times a day
Measure Participants	10
number of Corneal filaments at baseline	5.8 (2.9)
number of Corneal filaments at week 4	2.1 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mucinex
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.04
	Comments	A two tail P value of less than 0.05 was considered statistically significant.
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Change in OSDI Score
Description	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.
Time Frame	baseline (day 1) and week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mucinex
Arm/Group Description	600 mg of Mucinex 2 times a day. Mucinex®: Mucinex®
Measure Participants	10
OSDI score at baseline	55.6 (25.0)
OSDI score at week 4	46.1 (30.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mucinex
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.2
	Comments	A two tail P value of less than 0.05 was considered statistically significant.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	From study start following enrollment to study completion (4 weeks).
Adverse Event Reporting Description	All the subjects once enrolled into study were followed till they completed their week 4 follow-up visit and were asked about any AE. The PI's contact information was listed on ICF for the subjects to call in course of any AE.
Arm/Group Title	Mucinex (Intervetiion)
Arm/Group Description	600 mg of Mucinex, 2 times a day, for 4 weeks.
All Cause Mortality
	Mucinex (Intervetiion)
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Mucinex (Intervetiion)
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Mucinex (Intervetiion)
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.