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

NCT05814757 | Completed Phase 2 FDA Drug

• 1 other identifier: OTX-DED-2022-C01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes; Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Severity of Eye Dryness Score (visual analogue scale (VAS))

  Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)

  Change from baseline (CFB) at Day 15

Study Arms (3)

OTX-DED 0.3mg

EXPERIMENTAL

Drug: OTX-DED

Controlled Insertion utilizing Collagen Punctal Plug

EXPERIMENTAL

Drug: Controlled Insertion

Collagen Punctal Plug (Full Insertion)

PLACEBO COMPARATOR

Drug: Collagen Punctal Plug

Interventions

OTX-DED DRUG

0.3mg dexamethasone ophthalmic insert

OTX-DED 0.3mg

Controlled Insertion DRUG

Collagen Punctal Plug 0.2mm (Controlled Insertion)

Controlled Insertion utilizing Collagen Punctal Plug

Collagen Punctal Plug DRUG

Collagen Punctal Plug 0.2mm (Full Insertion)

Collagen Punctal Plug (Full Insertion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (1)

Ocular Therapeutix

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Eye Diseases

Interventions

Punctal Plugs

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Masked Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 18, 2023
• Study Start: May 11, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)