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

NCT00407043 | Completed Phase 4 DMC

• 1 other identifier: Donnenfeld Review 1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease; Keratoconjunctivitis Sicca

Keywords

Dry Eye Disease; Lotemax; Restasis; Loteprednol; Cyclosporine

Outcome Measures

Primary Outcomes (4)

• Ocular Surface Disease Questionnnaire Results

• Lissamine green staining

• Fluorescein Staining

• Schirmer testing

Interventions

Lotemax DRUG

Restasis DRUG

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ophthalmic Consultants of Long Island: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Related Publications (1)

• 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.

  PMID: 25083776 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

Loteprednol Etabonate; Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Maria Howard

  Ophthalmic Consultants of Long Island

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2006
• First Posted: December 4, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

US (1)