A Phase II Study of AL-15469A /AL-38905 for Treatment of Marginal Corneal Infiltrates

This study has been terminated.

First Received: December 19, 2007 Last Updated: February 12, 2009 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00579020

Purpose

The purpose of the study is to determine whether AL-15469A / AL-38905 ophthalmic formulation is safe and effective in treating marginal corneal infiltrates

Condition	Intervention	Phase
Marginal Corneal Infiltrates	Drug: AL-15469A / AL-38905 Ophthalmic Formulation	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Resolution of all corneal stromal infiltrate(s) in the study eye at Day 10 (TOC) [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- Resolution (i.e. rating of normal) of bulbar conjunctival injection at Day 10 (TOC) - Eradication of pre-therapy pathogens at Day 10 (TOC) - Mean score of bulbar conjunctival injection at Day 10 (TOC) - Mean change in corneal stromal infiltrate size [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AL-15469A / AL-38905 Ophthalmic Formulation Eye drop
2: Active Comparator	Drug: AL-15469A / AL-38905 Ophthalmic Formulation Eye drop

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection, in at least one eye

Exclusion Criteria:

Age related

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579020

Locations

United States, Texas
SA TX
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Rekha Garadi, Ph.D.

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon ( George Wall )
Study ID Numbers:	C-05-04
Study First Received:	December 19, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00579020 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

cornea
inflammation
blepharitis
lid infection

Study placed in the following topic categories:

Corneal Diseases
Blepharitis
Tetrahydrozoline
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009