None listed
Conditions
Brief summary
This early phase study is to assess the pharmacokinetics (how the body processes a drug), safety, and tolerability of ILYX-002 administered as an eye drop. ILYX-002 is being developed as a potential treatment for Dry Eye Disease. In this study, approximately 16 generally healthy male and female adults will be enrolled. Fourteen will receive ILYX-002 and two will receive vehicle, which is an eye drop of similar makeup except no active drug substance. Participants will stay at the study center for a total of 9 days. While residing at the study center, participants will receive their assigned study treatment approximately twice per day, be monitored closely for safety and tolerability, and have multiple, repeat blood draws. After discharge, participants will return for a final safety follow-up visit on Day 15. The total study duration will be up to 6 weeks, including a 4-week window for screening and determination of eligibility.
Interventions
ILYX-002 (0.3%) is a sterile, isotonic, preservative-free topical ophthalmic suspension. ILYX-002 will be administered by designated, unmasked site staff to the participant twice a day for 7 days plus a single dose in the morning on Day 8. The dosage is 1 drop in each eye per administration.
Participants will stay at the study center for a total of 9 days. Masked study treatment assignment will occur on Day 1 at the time of kit allocation. Each kit contains either ILYX-002 or vehicle, and there
ILYX-002 (0.3%) is a sterile, isotonic, preservative-free topical ophthalmic suspension. ILYX-002 will be administered by designated, unmasked site staff to the participant twice a day for 7 days plus a single dose in the morning on Day 8. The dosage is 1 drop in each eye per administration. Participants will stay at the study center for a total of 9 days. Masked study treatment assignment will occur on Day 1 at the time of kit allocation. Each kit contains either ILYX-002 or vehicle, and there will be one kit assigned per participant. The Investigator, or designee, will be provided a group-specific, masked “Kit Allocation Scheme” that includes a randomly determined, prespecified list of kit identification numbers based on the number of eligible participants scheduled for each group. Allocation will occur in order based on the sequential confirmation of participant eligibility on Day 1 prior to dosing. While residing at the study center, participants will receive their assigned study treatment (ILYX-002 or vehicle) approximately twice per day, be monitored closely for safety and tolerability, and have multiple, repeat blood draws. After discharge, participants will return for a final safety follow-up visit on Day 15. The total study duration will be up to 6 weeks, including a 4-week window for screening and determination of eligibility.
Sponsors
Iolyx Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, 18 to 70 years of age 2. Must be in good general health 3. Body mass index greater than or equal to 18 and less than 35 4. Willing to discontinue use of alcohol, caffeine, tobacco, and cannabis at least 24 hours prior to and during the inpatient portion of the study
Exclusion criteria
1. Any history of severe ocular trauma in either eye 2. Current or recent history of ocular infection or inflammation in either eye within 3 months prior to screening 3. Within 15 days prior to screening have taken, used, or anticipate using contraindicated ophthalmic medications or devices 4. Anticipated use of contact lenses in either eye during the study 5. Ocular surface or anterior segment surgery within 1 year prior to screening 6. History of glaucoma or actively being treated for glaucoma 7. History of punctal cautery at any time in either eye 8. Positive alcohol breath and/or urine drug screen
Outcome results
None listed