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

A 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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05814757

Enrollment

100

Registered

2023-04-18

Start date

2023-05-11

Completion date

2024-05-22

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Eye Diseases

Brief summary

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

Detailed 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.

Interventions

DRUGOTX-DED

0.3mg dexamethasone ophthalmic insert

DRUGControlled Insertion

Collagen Punctal Plug 0.2mm (Controlled Insertion)

DRUGCollagen Punctal Plug

Collagen Punctal Plug 0.2mm (Full Insertion)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double (Participant, Masked Investigator)

Intervention model description

Parallel: Participants are assigned to one of three groups in parallel for the duration of the study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Severity of Eye Dryness Score (visual analogue scale (VAS))	Change from baseline (CFB) at Day 15	Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026