Trial Outcomes & Findings for Mucinex® for Treatment of Filamentary Keratitis (NCT NCT02859246)

Results Overview

Change was calculated as the value after receiving treatment with guaifenesin for 4 weeks minus the value at baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

baseline (day 1) and week 4

Results posted on

2020-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Mucinex 600 mg of Mucinex 2 times a day. Mucinex®: Mucinex®
Overall Study STARTED	15
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Mucinex 600 mg of Mucinex 2 times a day. Mucinex®: Mucinex®
Overall Study Screen fails	3
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mucinex n=12 Participants 600 mg of Mucinex 2 times a day. Mucinex®: Mucinex®
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=12 Participants
Age, Categorical >=65 years	6 Participants n=12 Participants
Age, Continuous	63.7 years n=12 Participants
Sex: Female, Male Female	5 Participants n=12 Participants
Sex: Female, Male Male	7 Participants n=12 Participants
Region of Enrollment United States	12 Participants n=12 Participants
Number of Corneal Filaments in both eyes	2.1 number of corneal filaments STANDARD_DEVIATION 2.2 • n=12 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mucinex n=10 Participants 600 mg of Mucinex 2 times a day
Change in Number of Corneal Filaments number of Corneal filaments at baseline	5.8 corneal filaments Standard Deviation 2.9
Change in Number of Corneal Filaments number of Corneal filaments at week 4	2.1 corneal filaments Standard Deviation 2.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mucinex n=10 Participants 600 mg of Mucinex 2 times a day
Change in OSDI Score OSDI score at baseline	55.6 score on a scale Standard Deviation 25.0
Change in OSDI Score OSDI score at week 4	46.1 score on a scale Standard Deviation 30.9

Adverse Events

Mucinex (Intervetiion)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Reza Dana

Massachusetts Eye and Ear Infirmary

Phone: 617-573-4331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place