Corneal DiseasesNCT00029185
Study of Dehydrex in Patients With Corneal Erosion
A study testing Dehydrex in people with Corneal Diseases and Recurrence, run by Holles Laboratories, Inc. at 1 site in United States.
Trial summary
This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Diseases, Recurrence
- What is being tested?
- Dehydrex
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of symptomatic recurrent corneal syndrome due to anterior membrane dystrophy or posttraumatic abrasion
- Not responsive to standard medical therapy with artificial tears, hypertonic saline, or bandage soft contact lenses
- At least 3 episodes of erosion within the past 4 months documented by slit lamp examination
Who cannot join
- Allergy to any component of the medications to be used
- Active ocular surface infection due to bacteria, virus, or fungus
- Chronic atopic disease affecting the ocular surface or adnexa
- Dry eye, exposure, trichiasis, entropion, ectropion, or neurotrophic keratopathy
- Concurrent use of contact lenses
- Diagnosis of persistent epithelial defect in eye to be treated
Show all 14Show fewer
- Concurrent use of topical medication to eye to be treated
- Any ocular eyelid surgery within the past 6 months
- Pre-existing corneal stromal edema
- Diabetes mellitus
- Postsurgical infection
- Dry eye condition of 16 or greater on Patient's Dry Eye Questionnaire
- Other investigational medications within the past 6 months
- Other corneal dystrophy
Trial locations and contacts
1 site in 1 country.
United States1 site
Holles Laboratories, Inc.
Cohasset, Massachusetts, 02025
About this study
Official title: Topical Dehydrex in Treating Recurrent Corneal Erosion
This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.
Read the detailed description
This study continues to provide Dehydrex to patients who have received it previously under other studies. Patients continue to be treated with their current dose of Dehydrex. Upward dose adjustments may be made as clinically indicated. Patients undergo eye exams every 3 to 4 months or more often. Downward dose titration will be attempted in patients who are stable, free of symptoms, and willing to attempt downward adjustments. In patients who are able to discontinue the medication, duration of healing will be determined. In those patients who experience a recurrence after discontinuing the medication, Dehydrex will be restarted at a dose higher than the minimum effective dose. After at least 8 weeks of treatment and resolution of symptoms, the dose may again be reduced. Further attempts to discontinue the medication will not be made.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Corneal Diseases, Recurrence
- Being tested
- Dehydrex
- Keywords
- Corneal Erosion, Dextrans, Administration, Topical, Ophthalmic Solutions, Thimerosal
- Medical subject headings
- Corneal Diseases, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DehydrexDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2002 (estimated)
- Study startSep 2001
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseasesStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holles Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029185
- Sponsor's protocol ID
- FD-R-1984-01
- Other IDs
- FD-R-001984-01
- Status last verified
- Oct 2001
- First submitted
- 8 Jan 2002
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Dehydrex in Treating Recurrent Corneal Erosion
- ClinicalTrials.gov ID
- NCT00029185
- Acronym / sponsor ID
- FD-R-1984-01
- Conditions
- Corneal Diseases, Recurrence
- Keywords
- Corneal Erosion, Dextrans, Administration, Topical, Ophthalmic Solutions, Thimerosal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Holles Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2001
- Study completion
- Sep 2007
- First posted
- 9 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.
Detailed description
This study continues to provide Dehydrex to patients who have received it previously under other studies. Patients continue to be treated with their current dose of Dehydrex. Upward dose adjustments may be made as clinically indicated. Patients undergo eye exams every 3 to 4 months or more often. Downward dose titration will be attempted in patients who are stable, free of symptoms, and willing to attempt downward adjustments. In patients who are able to discontinue the medication, duration of healing will be determined. In those patients who experience a recurrence after discontinuing the medication, Dehydrex will be restarted at a dose higher than the minimum effective dose. After at least 8 weeks of treatment and resolution of symptoms, the dose may again be reduced. Further attempts to discontinue the medication will not be made.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of symptomatic recurrent corneal syndrome due to anterior membrane dystrophy or posttraumatic abrasion
- Not responsive to standard medical therapy with artificial tears, hypertonic saline, or bandage soft contact lenses
- At least 3 episodes of erosion within the past 4 months documented by slit lamp examination
Key exclusion criteria (14 listed)
- Allergy to any component of the medications to be used
- Active ocular surface infection due to bacteria, virus, or fungus
- Chronic atopic disease affecting the ocular surface or adnexa
- Dry eye, exposure, trichiasis, entropion, ectropion, or neurotrophic keratopathy
- Concurrent use of contact lenses
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 |
|---|---|---|
| Dehydrex | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydrex in people with Corneal Diseases and Recurrence, run by Holles Laboratories, Inc. 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 3 inclusion and 14 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 25 Mar 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 25 Mar 2015.