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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: 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 CONDITION: Glaucoma PRIMARY OUTCOME: FT011 level in the aqueous humor (single sample time point) FT011 level in the tenon's capsule (single sample time point) SECONDARY OUTCOME: Ocular safety of FT011 assessed by eye examinations 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
Epistemonikos ID: 1143459f5c6d0a3417457abc545d9dbbd77b337a
First added on: Aug 24, 2024