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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

November 30, 2006
December 4, 2006
July 21, 2011
November 2006
September 2007   (Final data collection date for primary outcome measure)
  • Ocular Surface Disease Questionnnaire Results
  • Lissamine green staining
  • Fluorescein Staining
  • Schirmer testing
Same as current
Complete list of historical versions of study NCT00407043 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine

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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Dry Eye Disease
  • Keratoconjunctivitis Sicca
  • Drug: Lotemax
  • Drug: Restasis
Not Provided
Sheppard JD, Donnenfeld ED, Holland EJ, Slonim CB, Solomon R, Solomon KD, McDonald MB, Perry HD, Lane SS, Pflugfelder SC, Samudre SS. Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. Eye Contact Lens. 2014 Sep;40(5):289-96. doi: 10.1097/ICL.0000000000000049.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2007
September 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Donnenfeld Review 1
Not Provided
Not Provided
Dr. Eric Donnenfeld, OCLI
Ophthalmic Consultants of Long Island
Bausch & Lomb Incorporated
Study Director: Maria Howard Ophthalmic Consultants of Long Island
Ophthalmic Consultants of Long Island
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP