Study of Dehydrex in Patients With Corneal Erosion

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dehydrex

About this trial

This is an interventional treatment trial for Corneal Diseases focused on measuring Corneal Erosion, Dextrans, Administration, Topical, Ophthalmic Solutions, Thimerosal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Holles Laboratories, Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00029185

First Posted

January 8, 2002

Last Updated

March 24, 2015

Sponsor

Holles Laboratories, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00029185

Brief Title

Study of Dehydrex in Patients With Corneal Erosion

Official Title

Topical Dehydrex in Treating Recurrent Corneal Erosion

Study Type

Interventional

2. Study Status

Record Verification Date

October 2001

Overall Recruitment Status

Completed

Study Start Date

September 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Holles Laboratories, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Diseases, Recurrence

Keywords

Corneal Erosion, Dextrans, Administration, Topical, Ophthalmic Solutions, Thimerosal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dehydrex

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Facility Information:

Facility Name

Holles Laboratories, Inc.

City

Cohasset

State/Province

Massachusetts

ZIP/Postal Code

02025

Country

United States

Corneal Diseases, Recurrence

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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