Back to resultsMulticenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
Primary Purpose
Dry Eye Disease, Keratoconjunctivitis Sicca
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lotemax
Restasis
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease focused on measuring Dry Eye Disease, Lotemax, Restasis, Loteprednol, Cyclosporine
Eligibility 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.
Sites / Locations
- Ophthalmic Consultants of Long Island
Outcomes
Primary Outcome Measures
Ocular Surface Disease Questionnnaire Results
Lissamine green staining
Fluorescein Staining
Schirmer testing
Secondary Outcome Measures
Full Information
NCT ID
NCT00407043
First Posted
November 30, 2006
Last Updated
July 20, 2011
Sponsor
Ophthalmic Consultants of Long Island
Collaborators
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00407043
Brief Title
Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ophthalmic Consultants of Long Island
Collaborators
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease, Keratoconjunctivitis Sicca
Keywords
Dry Eye Disease, Lotemax, Restasis, Loteprednol, Cyclosporine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lotemax
Intervention Type
Drug
Intervention Name(s)
Restasis
Primary Outcome Measure Information:
Title
Ocular Surface Disease Questionnnaire Results
Title
Lissamine green staining
Title
Fluorescein Staining
Title
Schirmer testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Howard
Organizational Affiliation
Ophthalmic Consultants of Long Island
Official's Role
Study Director
Facility Information:
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25083776
Citation
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.
Results Reference
derived
Learn more about this trial
Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
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