Filamentary KeratitisNCT02859246

Mucinex® for Treatment of Filamentary Keratitis

A study testing Mucinex® in people with Filamentary Keratitis, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Filamentary Keratitis
What is being tested?: Mucinex®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Sep 2016to Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with filamentary keratitis
18 years and older

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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.

Conditions: Filamentary Keratitis
Being tested: Mucinex®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mucinex®Drug
Also called Guaifenesin
Mucinex®

Study groups in NCT02859246
Study group	Role	What they receive
Mucinex	Other	600 mg of Mucinex 2 times a day. Receives: Drug: Mucinex®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline (day 1) and week 4

Secondary outcomes (1)

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.
Measured: baseline (day 1) and week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Jul 2018

First posted9 Aug 2016 (estimated)
Study startSep 2016
Primary completionJul 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Filamentary KeratitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02859246
Sponsor's protocol ID: 16-044H
Status last verified: Feb 2020
First submitted: 4 Aug 2016
Last updated: 19 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mucinex® for Treatment of Filamentary Keratitis
ClinicalTrials.gov ID: NCT02859246
Acronym / sponsor ID: 16-044H
Conditions: Filamentary Keratitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
Study start: Sep 2016 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 9 Aug 2016 (estimated)
Results: Posted 19 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mucinex	Other	Drug: Mucinex®600 mg of Mucinex 2 times a day.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with filamentary keratitis
18 years and older

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mucinex®Also: GuaifenesinMucinex®	Drug	Mucinex

Primary outcome

Change in Number of Corneal Filaments
Time frame: 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.

1 secondary outcome

Change in OSDI Score
Time frame: baseline (day 1) and week 4

Results and safety

Results posted to the registry on 19 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mucinex	15	10

Primary outcome: Change in Number of Corneal Filaments

Time frame: baseline (day 1) and week 4. Mean (Standard Deviation). Unit: corneal filaments

Measure	Mucinex n = 10
number of Corneal filaments at baseline	5.8 (2.9)
number of Corneal filaments at week 4	2.1 (2.2)

Mucinex: p <0.04, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From study start following enrollment to study completion (4 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mucinex (Intervetiion)	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Reza Dana, M.D,MPH,M.Sc principal investigator

Massachusetts Eye and Ear Infirmary

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mucinex® in people with Filamentary Keratitis, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Corneal Filaments (time frame: baseline (day 1) and week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02859246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.