OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)

Ocular Therapeutix

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes; Eye Diseases

Treatments: Drug: Collagen Punctal Plug; Drug: Controlled Insertion; Drug: OTX-DED

Study type: Interventional

Funder types: Industry

Identifiers

NCT05814757

OTX-DED-2022-C01

Details and patient eligibility

About

To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED

Full description

Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
• Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
• Unanesthetized Schirmer of > 0 and ≤ 10 mm.
• Must not have used Artificial Tears during the Screening period.
• IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.

Exclusion criteria

• Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
• Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) < 5 mmHg or > 24 mmHg.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups, including a placebo group

OTX-DED 0.3mg

Experimental group

Treatment:

Drug: OTX-DED

Controlled Insertion utilizing Collagen Punctal Plug

Experimental group

Treatment:

Drug: Controlled Insertion

Collagen Punctal Plug (Full Insertion)

Placebo Comparator group

Treatment:

Drug: Collagen Punctal Plug