A Phase 1/2 interventional study of Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA in Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal, sponsored by Eyegate Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-30.
Sponsored by Eyegate Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment
To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a posterior chamber intraocular lens (IOL)
This will be a Phase 1b/2a, open-label, multi-site study, in which a total of up to 20 eyes of up to 20 patients will be enrolled. Patients having undergone unilateral cataract surgery with implantation of a posterior chamber monofocal intraocular lens (IOL) who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include best corrected visual acuity (BCVA), slit lamp examination, conjunctival injection, and intraocular pressure (IOP) by tonometry will be used to determine eligibility just prior to cataract surgery on Day 0. Eligible subjects will undergo iontophoresis treatment immediately post-cataract surgery on Day 0 and Day 7, and will return to the clinic for examination on Days 1, 14, and 28.
Eyegate Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Drug: Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA
Drug page: Dexamethasone phosphate
Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA
Also known as: EGP-437
The proportion of subjects with an anterior chamber cell count of zero on Day 14
Time frame: Day 14
The proportion of subjects with a pain score of zero on Day 7
Time frame: Day 7
Plan to share: Undecided
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone phosphate
Eyegate Pharmaceuticals, Inc.