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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02859246
Other study ID # 16-044H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date July 2018

Study information

Verified date February 2020
Source Massachusetts Eye and Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Mucinex®
Mucinex®

Locations

Country Name City State
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in OSDI Score 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.
baseline (day 1) and week 4
See also
  Status Clinical Trial Phase
Completed NCT05891106 - AONDA Therapeutic Indication Study I

External Links