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Dexamethasone Eye Drops for Post-Cataract Surgery Care (OPTIMIZE-2 Trial)

Phase 3
Recruiting
Research Sponsored by Oculis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 6 (day 15)
Awards & highlights

OPTIMIZE-2 Trial Summary

This trial tests if a new drug is safe & effective for treating eye inflammation & pain after surgery.

Who is the study for?
This trial is for adults of any sex or race who are undergoing cataract surgery and will have an intraocular lens implanted. Participants must be able to follow the study plan and visits, and have a certain level of inflammation after surgery. People with allergies to dexamethasone or corticosteroids, those with one functional eye, or pre-existing eye inflammation can't join.Check my eligibility
What is being tested?
The study tests OCS-01 Eye Drops against a placebo (vehicle of OCS-01) to see if they're effective in reducing pain and inflammation after cataract surgery. Patients receive either the actual medication or placebo without knowing which one.See study design
What are the potential side effects?
Possible side effects may include reactions at the application site like burning or stinging sensation, increased risk of infection due to immune suppression by steroids, elevated eye pressure, and potential worsening of existing infections.

OPTIMIZE-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a specific cataract surgery in one eye.

OPTIMIZE-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 6 (day 15)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 6 (day 15) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery
To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

OPTIMIZE-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OCS-01Experimental Treatment1 Intervention
dexamethasone ophthalmic suspension,1.5% [15 mg/mL]
Group II: Vehicle ophthalmic suspensionPlacebo Group1 Intervention
Vehicle of OCS-01

Find a Location

Who is running the clinical trial?

OculisLead Sponsor
8 Previous Clinical Trials
1,570 Total Patients Enrolled
2 Trials studying Cataract
393 Patients Enrolled for Cataract
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,792 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned OCS-01 for commercial use?

"Through our evaluations, OCS-01 was assigned a safety rating of 3 due to the available evidence from Phase 3 trials that supports its efficacy and the multiple rounds of data collected regarding its safe use."

Answered by AI

How many geographically dispersed locations are administering this experiment?

"Currently, the trial is enrolling patients from 12 different locations, including Morrow, Louisville and Saint Louis. It would be beneficial for candidates to select a clinic located nearby in order to reduce travel requirements if they are accepted into the study."

Answered by AI

Are any more participants being taken in for this experiment?

"As per clinicaltrials.gov, this trial is no longer accepting patients at the moment; nonetheless, there are numerous other medical studies searching for volunteers with a total of 1,006 trials currently in progress. The trial originally appeared on December 1st 2023 and was most recently altered on November 7th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
Oculis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery
2023. "Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128369.
All > Montreal > Cataract
~53 spots leftby Jul 2024
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