Back to resultsOTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
Primary Purpose
Dry Eye Syndromes, Eye Diseases
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTX-DED
Controlled Insertion
Collagen Punctal Plug
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
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.
Sites / Locations
- Ocular TherapeutixRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
OTX-DED 0.3mg
Controlled Insertion utilizing Collagen Punctal Plug
Collagen Punctal Plug (Full Insertion)
Arm Description
Outcomes
Primary Outcome Measures
Severity of Eye Dryness Score (visual analogue scale (VAS))
Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05814757
Brief Title
OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Eye Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Masked Investigator)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OTX-DED 0.3mg
Arm Type
Experimental
Arm Title
Controlled Insertion utilizing Collagen Punctal Plug
Arm Type
Experimental
Arm Title
Collagen Punctal Plug (Full Insertion)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OTX-DED
Intervention Description
0.3mg dexamethasone ophthalmic insert
Intervention Type
Drug
Intervention Name(s)
Controlled Insertion
Intervention Description
Collagen Punctal Plug 0.2mm (Controlled Insertion)
Intervention Type
Drug
Intervention Name(s)
Collagen Punctal Plug
Intervention Description
Collagen Punctal Plug 0.2mm (Full Insertion)
Primary Outcome Measure Information:
Title
Severity of Eye Dryness Score (visual analogue scale (VAS))
Description
Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
Time Frame
Change from baseline (CFB) at Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Project Manager
Phone
781-357-4000
Email
clinicalaffairs@ocutx.com
Facility Information:
Facility Name
Ocular Therapeutix
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Email
clinicalaffairs@ocutx.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
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