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Clinical trials
Clinical study results
According to both XG-102 and XG-104 pipelines, the following clinical trials are currently or were performed in the specified indications.
Moreover in a matter of transparency and public disclosure, every clinical study performed with both products will be made publicly available on this web-site, containing title, summary and trial identification code for ongoing studies and title and links to public registry for completed studies.
Moreover in a matter of transparency and public disclosure, every clinical study performed with both products will be made publicly available on this web-site, containing title, summary and trial identification code for ongoing studies and title and links to public registry for completed studies.
Completed studies
- SDD-1002-035: A randomized, double-blind, parallel group, controlled, multicenter trial to assess the efficacy and safety of a single sub-conjunctival injection of XG-102, compared to dexamethasone eye drops in post-surgery intraocular. Inflammation.
- SDD-1004-037: A safety, tolerability and pharmacokinetics of single and repeated topical doses of XG-104 administered to healthy male volunteers in a randomized, double blind, placebo controlled at each dose level Phase I study.
- SDD-1002-023: Dose escalation study to assess the safety and tolerability of sub-conjunctival injections of XG-102 in patients with post-surgery or post-traumatic intraocular inflammation.
- SDD-1002-024: Safety, Tolerability and PK of a Single iv Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Volunteers (NCT01570205).
- AM-111-CL-08-01: Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss (NCT00802425).
- SDD-1002-064 : A Multicenter, Randomized, Double-masked, Vehicle-controlled, Parallel Group Phase III Study of the Efficacy and Safety of a Single Sub-conjunctival Injection of XG-102 for the Reduction of Post-cataract Surgery Intraocular Inflammation.
- SDD-1002-065: A Multicenter, Randomized, Double-masked, Vehicle-controlled, Parallel Group Phase III Study of the Efficacy and Safety of a Single Sub-conjunctival Injection of XG-102 for the Reduction of Post-cataract Surgery Intraocular Inflammation.
- SDD-1004-059: A Phase II, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of XG-104 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAESM ) Model for the Treatment of Dry Eye.
- SDD-1004-058: The safety, tolerability and pharmacokinetics (plasma and urine) of a single intravenous infusion of 20, 70, 200, 400 and 700 µg/kg XG-104 administered to healthy male volunteers in a randomized, double-blind, placebo-controlled, dose escalating Phase I study.
- AM-111: Intratympanic treatment of acute acoustic trauma with a cell-permeable JNK ligand: a prospective randomized phase I/II study.
