Filamentary Keratitis
Conditions
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.
Interventions
DRUGMucinex®
Mucinex®
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mucinex 600 mg of Mucinex 2 times a day.
Mucinex®: Mucinex® | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Screen fails | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Mucinex | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 63.7 years | — |
| Number of Corneal Filaments in both eyes | 2.1 number of corneal filaments STANDARD_DEVIATION 2.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 Participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: baseline (day 1) and week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mucinex | Change in Number of Corneal Filaments | number of Corneal filaments at baseline | 5.8 corneal filaments | Standard Deviation 2.9 |
| Mucinex | Change in Number of Corneal Filaments | number of Corneal filaments at week 4 | 2.1 corneal filaments | Standard Deviation 2.2 |
p-value: <0.04Wilcoxon (Mann-Whitney)
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.
Time frame: baseline (day 1) and week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mucinex | Change in OSDI Score | OSDI score at baseline | 55.6 score on a scale | Standard Deviation 25 |
| Mucinex | Change in OSDI Score | OSDI score at week 4 | 46.1 score on a scale | Standard Deviation 30.9 |
p-value: <0.2Wilcoxon (Mann-Whitney)