Current and Future Clinical Trials

Current investigations to help participants with:

Sjogren’s Disease
Ocular Graft-versus-Host Disease

Glaucoma and Ocular Hypertension
Early Keratoconus in one or both eyes
Ocular discomfort or ocular pain in participants with moderate to severe dry eye disease.

Phase I Mild to moderate keratoconus patients aged 18-40 years old for Novel topical intervention for prevention of progression of keratoconus. – OPEN NOW –

A proof of concept, randomized, open-label, three-cohort study to investigate the safety and preliminary efficacy of novel topical eyedrops in male and female adult volunteers with vision loss and in patients with progressive keratoconus. See more about looking for a cure for keratoconus.

Glaucoma and Ocular Hypertension – OPEN NOW (ACTRN12625000766415) – Phase 1, study designed to evaluate the safety, tolerability, and preliminary efficacy of investigational ophthalmic solutions in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Ocular Surface Pain – EOI OPEN SOON – Register Now, filling fast –

A phase 1 and phase 2 clinical trial for participants with moderate ocular surface pain study to investigate the safety and preliminary efficacy of novel topical eyedrops.

Phase II Sjögren’s Related Dry Eye Disease A 28 Day Trial (NCT07118241)– OPEN NOW –

A Phase II Prospective Randomized Crossover Study Assessing the Acute Safety & Efficacy of Investigational Product Compared to Vehicle for the Treatment of Sjögren’s Related Dry Eye Disease

Ocular Graft-Versus-Host Disease (oGVHD) (NCT07118254) – OPEN SOON –

A phase 2 prospective crossover design study for Ocular Graft-Versus-Host Disease (oGVHD).

Chronic Ocular Surface Pain (COSP) > 3 months – LTFU Capacity Met –

ETX4143-A002: Chronic Ocular Surface Pain (COSP) greater than 3 months in duration with or without dry eye. This Phase II clinical trial is a device and in-clinic treatment with LTFU.

Phase 4 Dry Eye Disease Clinical Trial – CAPACITY MET –

Post-market dry eye Phase IV clinical trial to assess the effectiveness of eye drops for dry eye on the market compared with novel formulations.

Dry Eye Disease Clinical Trial – COMPLETED –

ST-100-002: A Phase 3 Multi-Centre, Randomised, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 µg/ml in Subjects Diagnosed with Dry Eyes.

Sjögren’s Related Dry Eye Disease One Day Trial – CLOSED –

A Phase II Prospective Randomized Crossover Study Assessing the Acute Safety & Efficacy of Investigational Product Compared to Vehicle for the Treatment of Sjögren’s Related Dry Eye Disease

Dry Eye Disease with Autoimmune Disease Clinical Trial – COMPLETED –

ILYX-002-201: A Multicenter, Randomized, Controlled, Double-Masked Phase 2 Trial of the Safety and Therapeutic Effects of ILYX 002 Versus Vehicle Control for Treatment of Dry-Eye Disease in Patients with Autoimmune Disease

Ocular Graft-Versus-Host Disease (oGVHD) – COMPLETED –

rhPRG4-oGVHD-001: A phase 1 prospective open label study assessing the safety and efficacy of an investigational product for the treatment of Ocular Graft-Versus-Host Disease (oGVHD).

Ocular hypertension and reduction of intra-ocular pressure with an investigational cooling device. (NCT06709300) – POSTPONED –

A prospective, early-feasibility clinical study to evaluate the safety and effectiveness of a topical ophthalmic cooling device in patients with ocular hypertension.

In the OTA Pipeline – Please register your interest:

Our focus is on anterior eye, simply register your interest here and we will follow you up. 

To register your interest, email tracey@ot-au.com or call 07 3608 2074 and advise on which trial you are interested in.

Ophthalmic Trials Australia