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

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ClinicalTrials.gov Identifier: NCT00407043
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : July 21, 2011
Bausch & Lomb Incorporated
Information provided by:
Ophthalmic Consultants of Long Island

Brief Summary:

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 or disease Intervention/treatment Phase
Dry Eye Disease Keratoconjunctivitis Sicca Drug: Lotemax Drug: Restasis Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine
Study Start Date : November 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Ocular Surface Disease Questionnnaire Results
  2. Lissamine green staining
  3. Fluorescein Staining
  4. Schirmer testing

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407043

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United States, New York
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
Sponsors and Collaborators
Ophthalmic Consultants of Long Island
Bausch & Lomb Incorporated
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Study Director: Maria Howard Ophthalmic Consultants of Long Island
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Eric Donnenfeld, OCLI
ClinicalTrials.gov Identifier: NCT00407043    
Other Study ID Numbers: Donnenfeld Review 1
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011
Keywords provided by Ophthalmic Consultants of Long Island:
Dry Eye Disease
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Conjunctival Diseases
Corneal Diseases
Loteprednol Etabonate
Anti-Allergic Agents