Dry Eye Disease Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ophthalmic Consultants of Long Island | Lynbrook | New York |
Lead Sponsor | Collaborator |
---|---|
Ophthalmic Consultants of Long Island | Bausch & Lomb Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ocular Surface Disease Questionnnaire Results | |||
Primary | Lissamine green staining | |||
Primary | Fluorescein Staining | |||
Primary | Schirmer testing |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03216096 -
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease
|
Phase 1 | |
Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
Completed |
NCT04656197 -
The Ocular Microbiome in Patients With Dry Eye Disease
|
||
Completed |
NCT05031806 -
Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease
|
Phase 1 | |
Completed |
NCT03688802 -
Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
|
Phase 2 | |
Completed |
NCT05213156 -
Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
|
Phase 4 | |
Completed |
NCT04548427 -
Study to Evaluate the Efficacy and Safety of CKD-352
|
Phase 3 | |
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT02254265 -
Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
|
Phase 2/Phase 3 | |
Completed |
NCT00395759 -
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
|
N/A | |
Completed |
NCT00680108 -
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
|
Phase 2 | |
Recruiting |
NCT06064071 -
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
|
N/A | |
Completed |
NCT04139122 -
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06375343 -
Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®
|
Phase 1 | |
Completed |
NCT01468168 -
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
|
Phase 2 | |
Completed |
NCT01014078 -
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
|
Phase 4 | |
Completed |
NCT00799682 -
Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®
|
Phase 4 | |
Completed |
NCT05082974 -
Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK)
|
Phase 3 | |
Recruiting |
NCT06146881 -
Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
|
Phase 2 | |
Completed |
NCT03292809 -
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
|
Phase 2/Phase 3 |