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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR MAXIDEX

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Clinical Trials for Maxidex

Trial ID Title Status Sponsor Phase Summary
NCT00266838 Prevention of Docetaxel Induced Dacryostenosis Completed Universitaire Ziekenhuizen Leuven Phase 1 The antineoplastic agent Docetaxel (Taxotere®) is approved for the treatment of patients with metastatic and locally advanced breast cancer and other malignancies. There are 2 frequently used schedules of treatment with Docetaxel. Docetaxel can be administered every 3 weeks or in a weekly regimen. The efficacy seems to be similar but the toxicity profile changes. In the standard 3-weekly Docetaxel regimen the dose-limiting side effect is myelosuppression, while in the weekly regimen there is only a mild myelosuppression. On the other hand, weekly Docetaxel has a side effect that is rare in the 3-weekly schedule: epiphora (= tearing eye) caused by dacryostenosis. The underlying mechanism of dacryostenosis induced by weekly Docetaxel is fibrosis of the lacrimal puncta and canaliculi. Docetaxel has been reported to be secreted in the lacrimal tears. Direct contact between Docetaxel containing tears and the epithelial lining causes chronic inflammation of the mucosa and ultimately fibrosis of the most narrow part of the lacrimal outflow system i.e. the lacrimal puncta and canaliculi. A surgical treatment is possible for dacryostenosis. In case of subtotal stenosis of the lacrimal canaliculi, silicone intubation of the canaliculi is performed in order to prevent further closure. In the case of complete stenosis, placement of a permanent pyrex glass tube of Jones is required. To our knowledge, there is no primary prevention for Docetaxel induced dacryostenosis. The rationale of this randomized double blind interventional study is to investigate the efficacy of corticosteroid versus artificial tears topical eye treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in the lacrimal tears will be washed away by the repetitive use of eye drops. In addition, eye drops containing corticosteroids have an anti-inflammatory effect and may further prevent the formation of fibrosis. A new treatment protocol will be investigated. Two different commercially available eye drops will be compared: dexamethasone sodium phosphate (Maxidex®, Alcon) in one eye of the patient and artificial tears (Lacrystat®, Viatris) in the other eye of the same patient. The study period will start with topical eye treatment from day 1 of cycle 1 and will continue during the administration of chemotherapy, with a final analysis at 26 weeks.
NCT00631358 Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention Completed Alcon Research Phase 4 The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.
NCT01001091 AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation Completed Ophthalmic Research Associates, Inc. Phase 2 The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Maxidex

Condition Name

Condition Name for Maxidex
Intervention Trials
Allergic Conjunctivitis 2
Multiple Myeloma 1
Epiphora 1
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Condition MeSH

Condition MeSH for Maxidex
Intervention Trials
Conjunctivitis, Allergic 2
Conjunctivitis 2
Lacrimal Apparatus Diseases 1
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Clinical Trial Locations for Maxidex

Trials by Country

Trials by Country for Maxidex
Location Trials
United States 4
Canada 1
Belgium 1
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Trials by US State

Trials by US State for Maxidex
Location Trials
Massachusetts 2
New York 1
Texas 1
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Clinical Trial Progress for Maxidex

Clinical Trial Phase

Clinical Trial Phase for Maxidex
Clinical Trial Phase Trials
Phase 4 3
Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Maxidex
Clinical Trial Phase Trials
Completed 6
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Maxidex

Sponsor Name

Sponsor Name for Maxidex
Sponsor Trials
Alcon Research 4
Icahn School of Medicine at Mount Sinai 1
Ophthalmic Research Associates, Inc. 1
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Sponsor Type

Sponsor Type for Maxidex
Sponsor Trials
Other 6
Industry 6
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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Dow
Cipla
Chinese Patent Office
Citi
Teva
Medtronic
McKesson
Cerilliant

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