Filamentary Keratitis Clinical Trial
Official title:
Mucinex® for Treatment of Filamentary Keratitis
| 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 |
| Verified date | February 2020 |
| Source | Massachusetts Eye and Ear Infirmary |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts Eye and Ear Infirmary |
United States,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05891106 -
AONDA Therapeutic Indication Study I
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