None listed
Conditions
Brief summary
FT011 is being investigated as a potential drug to inhibit scar formation in the eye after surgery. The main aim of this study is to assess whether FT011 can enter the eye, as well as determine the safety of FT011 in the eye.
Interventions
Group 1: FT011 50mg orally once daily for 28 days, commencing 7 days prior to surgery
Group 2: FT011 100mg orally once daily for 28 days, commencing 7 days prior to surgery
Sponsors
Occurx Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Male or female, aged at least 18 years. - Have confirmed glaucoma. - Are scheduled to have trabeculectomy, tube surgery, or other glaucoma surgery, performed at the study site. - Agree to practice effective contraception (as outlined in the protocol) during the study period. - Provide written informed consent
Exclusion criteria
- pregnant or breastfeeding, or plan to become pregnant during the study - Have received any investigational drug within 5 half-lives or the 2 months prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer. - Have only one eye - Have active uveitis. - Have clinically significant ocular conditions other than glaucoma. - Have had ocular surgery in the 6 months prior to screening. - Have a known allergy to the investigational medicinal product (IMP). - Have any other medical condition or significant co-morbidities, or any finding during Screening, which may interfere with the study objectives in the investigator’s opinion. Have a history of or current clinically relevant social, clinical, or psychiatric condition which, in the opinion of the investigator, makes the participant unsuitable for participation in the study.
Outcome results
None listed