Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis - Full Text View

Sponsors and Collaborators:	Ophthalmic Consultants of Long Island Bausch & Lomb, Inc.
Information provided by:	Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier:	NCT00407043

Purpose

To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye.

It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.

Condition	Intervention	Phase
Dry Eye Disease Keratoconjunctivitis Sicca	Drug: Lotemax Drug: Restasis	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

Drug Information available for: Cyclosporine Cyclosporin Loteprednol etabonate Loteprednol

U.S. FDA Resources

Further study details as provided by Ophthalmic Consultants of Long Island:

Primary Outcome Measures:

Ocular Surface Disease Questionnnaire Results
Lissamine green staining
Fluorescein Staining
Schirmer testing

Estimated Enrollment:	120
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2006

Detailed Description:

Dry eye is an ocular surface disease that produces discomfort and irritation. Estimated prevalence ranges from 20 million people in the US being affected with mild to moderate dry eye, to as many as one out of every five Americans.

A growing body of evidence has associated ocular inflammation with the signs and symptoms of dry eye.

Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with a condition called keratoconjunctivitis sicca. The relief of dry eye signs and symptoms with Restasis therapy is often delayed by 1 to 6 months from the initiation of therapy. Stinging on installation, particularly when initiating therapy, has been reported.

Lotemax, an ophthalmic corticosteroid, targets inflammation with a unique, site-active mechanism of action.Structural modifications associated with an ester ophthalmic steroid make Lotemax highly lipid soluble, enhancing penetration into cells and enabling Lotemax to exert anti-inflammatory activity within the eye. Lotemax is indicated for the treatment of steroid responsive inflammatory conditions associated with the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Between the ages of 30 and 80 inclusive.
Has not worn contact lenses for at least 1 month prior to the study and agrees to not wear contact lenses during study.
Oral medications stable 1 month prior to study.
Oral medications anticipated to be stable during 60 day study.
Patient is in generally good & stable overall health.
Patient likely to comply with eye drop regimen, study guidelines & study visits.
Corneal stain > 1+ or Conjunctival stain > 1+ or OSDI equal or > 5 or using regular artificial tears at least on average twice daily.
Informed consent signed.

Exclusion Criteria:

History of Stevens-Johnson Syndrome or Ocular Pemphigoid.
Punctal plugs inserted or punctal cautery in the past 3 months.
Intra-ocular surgery within 6 months or ocular laser surgery within 3 months.
History of liver disease.
Pregnant or lactating women.
Severe clinical vitamin deficiencies or history of vitamin overdose.
Highly variable vitamin intake.
Unstable use of systemic or topical medications known to create dry eye.
Corneal pathology, which could, of itself, cause an ocular surface disorder.
Use of glaucoma medications, topical or oral.
Unstable diabetes mellitus.
Allergy or sensitivity to Lotemax, Restasis or the OTC Tear Supplement.
Use of topical steroids or Restasis within the past 1 month.
Use of other topical ocular agents other than tear replacements within the past 1 week.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407043

Contacts

Contact: Eric Donnenfeld, MD

516-766-2519

eddoph@aol.com

Locations

United States, New York
Ophthalmic Consultants of Long Island	Recruiting
Lynbrook, New York, United States, 11563
Principal Investigator: Eric Donnenfeld, MD

Sponsors and Collaborators

Ophthalmic Consultants of Long Island

Bausch & Lomb, Inc.

Investigators

Study Director:

Maria Howard

Ophthalmic Consultants of Long Island

More Information

No publications provided

Study ID Numbers:	Donnenfeld Review 1
Study First Received:	November 30, 2006
Last Updated:	December 4, 2006
ClinicalTrials.gov Identifier:	NCT00407043 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ophthalmic Consultants of Long Island:

Dry Eye Disease
Lotemax
Restasis
Loteprednol
Cyclosporine

Study placed in the following topic categories:

Corneal Diseases
Cyclosporine
Immunologic Factors
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Anti-Allergic Agents
Conjunctivitis
Immunosuppressive Agents

Keratoconjunctivitis
Loteprednol etabonate
Cyclosporins
Conjunctival Diseases
Xerophthalmia
Antifungal Agents
Keratitis
Antirheumatic Agents
Keratoconjunctivitis Sicca

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Loteprednol etabonate
Cyclosporins
Antifungal Agents
Therapeutic Uses
Dermatologic Agents
Keratoconjunctivitis Sicca

Corneal Diseases
Eye Diseases
Enzyme Inhibitors
Conjunctivitis
Anti-Allergic Agents
Keratoconjunctivitis
Immunosuppressive Agents
Conjunctival Diseases
Pharmacologic Actions
Xerophthalmia
Keratitis
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 06, 2009