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

Sponsor
Ocular Therapeutix, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05814757
Collaborator
(none)
100
1
3
10.1
9.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: OTX-DED
  • Drug: Controlled Insertion
  • Drug: Collagen Punctal Plug
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel: Participants are assigned to one of three groups in parallel for the duration of the studyParallel: Participants are assigned to one of three groups in parallel for the duration of the study
Masking:
Double (Participant, Investigator)
Masking Description:
Double (Participant, Masked Investigator)
Primary Purpose:
Treatment
Official Title:
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)
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: OTX-DED 0.3mg

Drug: OTX-DED
0.3mg dexamethasone ophthalmic insert

Experimental: Controlled Insertion utilizing Collagen Punctal Plug

Drug: Controlled Insertion
Collagen Punctal Plug 0.2mm (Controlled Insertion)

Placebo Comparator: Collagen Punctal Plug (Full Insertion)

Drug: Collagen Punctal Plug
Collagen Punctal Plug 0.2mm (Full Insertion)

Outcome Measures

Primary Outcome Measures

  1. Severity of Eye Dryness Score (visual analogue scale (VAS)) [Change from baseline (CFB) at Day 15]

    Visual Analogue Scale (0mm - no pain to 100mm - worst pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ocular Therapeutix Memphis Tennessee United States 38119

Sponsors and Collaborators

  • Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:
NCT05814757
Other Study ID Numbers:
  • OTX-DED-2022-C01
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023