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

Phase 1

Completed

• Conditions: Glaucoma; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12618000033246
• Lead Sponsor: Occurx Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-12
• Study Completion: 2020-01-31
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified