A Trial of the Safety and Therapeutic Effects of ILYX-002 Versus Vehicle Control for Treatment of Dry-Eye Disease in Patients with Autoimmune Disease

This trial is designed to evaluate the safety and tolerability and explore the potential therapeutic effects of repeat dosing of ILYX-002 compared to vehicle control in participants with dry-eye disease (DED) with autoimmune disease. This trial will include a sentinel cohort of 2 participants. The sentinel cohort will be conducted at a single-site as a single-masked, non-controlled, staggered-dosing design to evaluate the safety of low-dose (0.1%) and high-dose (0.3%) ILYX-002 administered as 1 drop in each eye twice daily through to Day 85. The first dose and each subsequent in-clinic dose will be administered under direct supervision at the study site and ongoing compliance with administration will be assessed by review of bottle returns at each visit. The dosing of sentinel participants will be staggered, with the safety profile of the initial sentinel participant gating the commencement of the second sentinel participant. Safety evaluation of each treatment arm at a minimum of 7 days of dosing will gate initiation of the Phase 2 trial. In the Phase 2 trial, participants will be randomised to 1 of the following 2 treatment groups in a 1:1 ratio as follows: Group 1: ILYX-002 0.3% (1 drop into each eye twice daily through to Day 57) Group 2: Vehicle (1 drop into each eye twice daily through to Day 57) The first dose and each subsequent in-clinic dose will be administered under direct supervision at the study site and the participant will continue twice-daily dosing at home until the next visit. Ongoing compliance with administration will be assessed by review of bottle returns at each visit. After Day 57, participants will continue to be monitored for safety until Day 71.