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Corticosteroid
Dexamethasone for Eye Disorders
Phase 3
Recruiting
Led By Oculis Investigative Site
Research Sponsored by Oculis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15
Awards & highlights
Study Summary
This trial will compare the effectiveness and safety of a new eye drop to a placebo in treating inflammation and pain after cataract surgery.
Eligible Conditions
- Post-Cataract Surgery Eye Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With an Absence of Anterior Chamber Inflammation
Eye pain
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Cerebrospinal fluid leak
2%
Deep Vein Thrombosis
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment ArmExperimental Treatment1 Intervention
OCS-01 (Ophthalmic Suspension) - topical use
Group II: Vehicle Placebo ArmPlacebo Group1 Intervention
Vehicle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
OculisLead Sponsor
8 Previous Clinical Trials
1,490 Total Patients Enrolled
Oculis Investigative SitePrincipal InvestigatorStudy Principal Investigator
1 Previous Clinical Trials
497 Total Patients Enrolled
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