Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg) for Dry Eye Syndrome

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Dry Eye SyndromeDextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a dexamethasone insert can reduce symptoms of dry eye disease.

Eligible Conditions
  • Dry Eye Syndrome

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Change from Baseline one month after intracanalicular insert implantation or punctal plug

Change from Baseline one month after intracanalicular insert implantation or punctal plug
Change in ocular inflammation
Clinical Parameter: Conjunctival staining
Clinical Parameter: Corneal staining with fluorescein
Clinical Parameter: Ocular Pain Assessment Survey (OPAS)
Clinical Parameter: Ocular Surface Disease Index (OSDI)
Clinical Parameter: Schirmer II test
Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)
Clinical Parameter: Tear Break Up Time (TBUT)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)
1 of 2
ProLong™ collagen plugs
1 of 2

Active Control

Non-Treatment Group

54 Total Participants · 2 Treatment Groups

Primary Treatment: Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg) · Has Placebo Group · Phase 4

ProLong™ collagen plugs
Other
PlaceboComparator Group · 1 Intervention: ProLong™ collagen plugs · Intervention Types: Other
Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)
Drug
ActiveComparator Group · 1 Intervention: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline one month after intracanalicular insert implantation or punctal plug

Who is running the clinical trial?

Ocular Therapeutix, Inc.Industry Sponsor
51 Previous Clinical Trials
5,290 Total Patients Enrolled
Tufts Medical CenterLead Sponsor
237 Previous Clinical Trials
244,929 Total Patients Enrolled
Pedram Hamrah, MDPrincipal InvestigatorTufts Medical Center
8 Previous Clinical Trials
1,713 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of dry eye disease.