NCT00029185

Brief Summary

This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2002

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 25, 2015

Status Verified

October 1, 2001

First QC Date

January 8, 2002

Last Update Submit

March 24, 2015

Conditions

Corneal DiseasesRecurrence

Keywords

Corneal ErosionDextransAdministration, TopicalOphthalmic SolutionsThimerosal

Interventions

DehydrexDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holles Laboratories, Inc.

Cohasset, Massachusetts, 02025, United States

Location

MeSH Terms

Conditions

Corneal DiseasesRecurrence

Condition Hierarchy (Ancestors)

Eye DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2002

First Posted

January 9, 2002

Study Start

September 1, 2001

Study Completion

September 1, 2007

Last Updated

March 25, 2015

Record last verified: 2001-10

Locations

US(1)