dexamethasone intracanalicular insert (OTX-DED) / Ocular Therapeutix - LARVOL DELTA

OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) (clinicaltrials.gov) - P2 | N=100 | Completed | Sponsor: Ocular Therapeutix, Inc. | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Ocular Therapeutix, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ May 2024

Enrollment closed • Trial completion date • Dry Eye Disease • Ophthalmology

OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Ocular Therapeutix, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Ocular Therapeutix, Inc.

New P2 trial • Dry Eye Disease • Ophthalmology

The DEPOT Study (Dry Eye Prescription Options for Therapy): Assessing the Efficacy and Safety of OTX-DED (Dexamethasone Ophthalmic Insert 0.3 mg) for Intracanalicular Use Compared with Loteprednol Suspension for the Treatment of Episodic Dry Eye. (PubMed, Clin Ophthalmol) - "IOP did not change significantly in patients with OTX-DED. These findings support the use of this unique intracanalicular insert for the treatment of acute dry eye once this product is approved and available for use."

Journal • Dry Eye Disease • Ophthalmology

Efficacy and Safety of OTX-DED Dexamethasone Intracanalicular Insert in Subjects with Dry Eye Disease: A Multicenter, Randomized, Vehicle-Controlled Phase 2 Study (ARVO 2022) - "OTX-DED 0.2 mg and 0.3 mg dexamethasone intracanalicular insert significantly improved bulbar conjunctival hyperemia compared to hydrogel-vehicle in subjects with dry eye disease. Both insert doses were generally safe and well-tolerated. Images: Bulbar Conjunctival Hyperemia Absolute Values in the Worst Zone on Day 15 Bulbar Conjunctival Hyperemia Change from Baseline in the Worst Zone on Day 15"

Clinical • P2 data • Dry Eye Disease • Ophthalmology

Efficacy of a Dexamethasone Intracanalicular Insert Compared to Loteprednol Suspension for the Treatment of Episodic Dry Eye (ASCRS-ASOA 2022) - "No significant change occurred in IOP among patients who received OTX-DED._x000D_ ConclusionWithin 14 days of treatment initiation, OTX-DED led to significant improvement in both objectively evaluated signs and subjective symptoms of dry eye disease, similar to topical loteprednol. OTX-DED may be a worthwhile treatment for rapid rehabilitation of the ocular surface without the burdens of topical therapy."

Clinical • Dry Eye Disease • Ophthalmology

Safety and Efficacy of an Intracanalicular Dexamethasone Insert for the Treatment of Episodic Dry Eye Disease: Phase 2 Study (ASCRS-ASOA 2022) - "Conclusion This Phase 2 study of two OTX-DED dexamethasone intracanalicular insert formulations (0.2 mg and 0.3 mg) showed statistically significant improvements in bulbar conjunctival hyperemia in patients with dry eye disease. Both formulations were generally safe and well-tolerated."

Clinical • P2 data • Dry Eye Disease • Immunology • Ophthalmology

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease (clinicaltrials.gov) - P2; N=166; Completed; Sponsor: Ocular Therapeutix, Inc.; Recruiting ➔ Completed; Trial completion date: Feb 2022 ➔ Sep 2021; Trial primary completion date: Dec 2021 ➔ Aug 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Ocular Therapeutix, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dry Eye Disease • Ophthalmology

[VIRTUAL] Ocular Pharmacokinetics of OTX-DED, a Sustained-release Intracanalicular Insert Delivering Dexamethasone, in a Canine Model (ARVO 2021) - "OTX-DED at a dose of 0.2 mg delivered dexamethasone to the ocular surface for approximately 14 days. Comparatively, DEXTENZA (0.4 mg) delivered dexamethasone to the ocular surface up to 28 days. In vivo dexamethasone release data indicates a shorter duration of drug release for the 0.2 mg dose compared to the 0.4 mg from the hydrogel insert in the beagle model."

PK/PD data • Preclinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease (clinicaltrials.gov) - P2; N=150; Not yet recruiting; Sponsor: Ocular Therapeutix, Inc.

Clinical • New P2 trial • Dry Eye Disease • Ocular Infections • Ophthalmology