Study of Dehydrex in Patients With Corneal Erosion | NCT00029185

Studies
Study of Dehydrex in Patients With Corneal Erosion

NCT00029185

Sponsor

Holles Laboratories, Inc.

Status

Completed

Last Update Posted

Mar 25, 2015Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Corneal Diseases
Recurrence

Interventions

Dehydrex

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FD-R-001984-01

Status Module

Record Verification Date

Oct 2001

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2001

Primary Completion Date

Not provided

Completion Date

Sep 2007

First Submitted Date

Jan 8, 2002

First Submission Date that Met QC Criteria

Jan 8, 2002

First Posted Date

Jan 9, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Name	Type	Description	Arm Group Labels	Other Names
Dehydrex	Drug

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Holles Laboratories, Inc.		Cohasset	Massachusetts	02025	United States

Condition Browse Module

MeSH Terms

ID	Term
D003316	Corneal Diseases
D012008	Recurrence

Ancestor Terms

ID	Term
D005128	Eye Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Not provided

Browse Branches

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