CompletedPhase 1ACTRN12618000033246

A double-blind, placebo-controlled, randomised trial to determine the ocular pharmacokinetics and safety of oral FT011 in patients with glaucoma.

Sponsor

Occurx Pty Ltd

Enrollment

8 participants

Start Date

May 13, 2019

Study Type

Interventional

Conditions

Glaucoma

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

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 Criteria9

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.

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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