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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-11

Study Completion Date

2024-05-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

NCT04747977

Dry Eye

COMPLETED PHASE2

Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)

NCT04527887

Dry Eye

TERMINATED PHASE4

OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

NCT02468700

Dry Eye

COMPLETED PHASE2

Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye

NCT04498468

Dry Eye

TERMINATED PHASE4

Assessing Dextenza Insert After SMILE Procedure

NCT04380857

Post Procedural Infection

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Syndromes Eye Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double (Participant, Masked Investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OTX-DED 0.3mg

Group Type EXPERIMENTAL

OTX-DED

Intervention Type DRUG

0.3mg dexamethasone ophthalmic insert

Controlled Insertion utilizing Collagen Punctal Plug

Group Type EXPERIMENTAL

Controlled Insertion

Intervention Type DRUG

Collagen Punctal Plug 0.2mm (Controlled Insertion)

Collagen Punctal Plug (Full Insertion)

Group Type PLACEBO_COMPARATOR

Collagen Punctal Plug

Intervention Type DRUG

Collagen Punctal Plug 0.2mm (Full Insertion)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OTX-DED

0.3mg dexamethasone ophthalmic insert

Intervention Type DRUG

Controlled Insertion

Collagen Punctal Plug 0.2mm (Controlled Insertion)

Intervention Type DRUG

Collagen Punctal Plug

Collagen Punctal Plug 0.2mm (Full Insertion)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No