Dexamethasone for Cataract

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
CataractDexamethasone - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether the medication DEXYCU is safe for treating inflammation following ocular surgery for childhood cataract.

Eligible Conditions
  • Cataract

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Post-Operative Day 14

Post-Operative Day 14
Grade of anterior chamber cells (ACC)
Grade of anterior chamber flare (ACF)

Trial Safety

Safety Progress

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

Side Effects for

Ondansetron
2%Cerebrospinal fluid leak
2%Deep Vein Thrombosis
2%Fever
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01474915) in the Ondansetron ARM group. Side effects include: Cerebrospinal fluid leak with 2%, Deep Vein Thrombosis with 2%, Fever with 2%.

Trial Design

2 Treatment Groups

Prednisolone acetate ophthalmic suspension (USP) 1%
1 of 2
DEXYCU (dexamethasoneintraocular suspension) 9%
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Dexamethasone · No Placebo Group · Phase 4

DEXYCU (dexamethasoneintraocular suspension) 9%
Drug
Experimental Group · 1 Intervention: Dexamethasone · Intervention Types: Drug
Prednisolone acetate ophthalmic suspension (USP) 1%
Drug
ActiveComparator Group · 1 Intervention: Prednisolone Acetate Ophthalmic · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: post-operative day 14

Who is running the clinical trial?

EyePoint Pharmaceuticals, Inc.Lead Sponsor
12 Previous Clinical Trials
1,594 Total Patients Enrolled
4 Trials studying Cataract
877 Patients Enrolled for Cataract

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Additional inclusion criteria may be specified in the protocol.
Having cataract surgery without complications, with or without an implant in the back of the eye.
If a contact lens is used to correct aphakia after surgery, it must be a silicone elastomer lens or a rigid gas permeable lens (not a water content lens).