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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
Must not have
Have only one functional eye (monocular)
Have any intraocular inflammation (e.g., white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit-lamp examination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 6 (day 15)
Awards & highlights
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I can see with only one of my eyes.
Select...
I have signs of eye inflammation detected in a recent exam.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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Who is running the clinical trial?

OculisLead Sponsor
8 Previous Clinical Trials
1,570 Total Patients Enrolled
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,799 Total Patients Enrolled
~87 spots leftby Nov 2025
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