Dexamethasone for Cataract

Phase-Based Progress Estimates
CataractDexamethasone - Drug
< 18
All Sexes
What conditions do you have?

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

2%Cerebrospinal fluid leak
2%Deep Vein Thrombosis
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%
Experimental Group · 1 Intervention: Dexamethasone · Intervention Types: Drug
Prednisolone acetate ophthalmic suspension (USP) 1%
ActiveComparator Group · 1 Intervention: Prednisolone Acetate Ophthalmic · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
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).