Inflammation Eye PainPhase 3OPTIMIZE-1NCT05147233

A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

A Phase 3 study testing OCS-01 in people with Inflammation Eye Pain and Postoperative Cataract, run by Oculis at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammation Eye Pain, Postoperative Cataract
What is being tested?: OCS-01
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 241 participants
Where: 25 sitesUnited States
Study dates: 24 Jun 2022to 3 Jul 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye.
Have a pin-hole visual acuity (VA) without any other correction > 20 letters (approximately 20/400) in the operative eye and > 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 [prior to surgery]).

Who cannot join

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.
Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Oculis Site 4
Austin, Texas, 78731
Oculis Site 6
Brecksville, Ohio, 44141
Oculis Site 16
Chandler, Arizona, 85224
Oculis Site 14
Cincinnati, Ohio, 45242
Oculis Site 25
Eugene, Oregon, 97401
Oculis Site 8
Fayetteville, Arkansas, 72704
Oculis Site 11
Fort Collins, Colorado, 80528
Oculis Site 10
Houston, Texas, 77025
Oculis Site 9
Inglewood, California, 90301
Oculis Site 7
Kingston, Pennsylvania, 18704
Oculis Site 13
Kinston, North Carolina, 28501
Oculis Site 20
Louisville, Kentucky, 40206
Oculis Site 30
Lynchburg, Virginia, 24502
Oculis Site 17
Morrow, Georgia, 30260
Oculis Site 23
Newport Beach, California, 92663
Oculis Site 26
Petaluma, California, 94954
Oculis Site 28
Phoenix, Arizona, 85003
Oculis Site 27
Salt Lake City, Utah, 84032
Oculis Site 2
San Antonio, Texas, 78229
Oculis Site 31
San Antonio, Texas, 78229
Oculis Site 24
San Pedro, California, 90731
Oculis Site 5
St Louis, Missouri, 63128
Oculis Site 12
Tamarac, Florida, 33321
Oculis Site 3
Washington, Missouri, 63090
Oculis Site 22
Westminster, California, 92683

Other trials in United States

About this study

Official title: A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery

Conditions: Inflammation Eye Pain, Postoperative Cataract
Being tested: OCS-01, Vehicle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OCS-01Drug
Dexamethasone ophthalmic suspension, 1.5%
VehicleDrug
Vehicle

Study groups in NCT05147233
Study group	Role	What they receive
OCS-01	Experimental	1 drop of OCS-01 (Dexamethasone ophthalmic suspension 1.5% [15 mg/mL]) in the study eye once daily (QD) for 14 days, beginning 1-day post-surgery in the study eye. Receives: Drug: OCS-01
Vehicle	Placebo comparator	1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye. Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Absence of Anterior Chamber Cells at Visit 6.
Measured: Day 15
Absence of Ocular Pain at Visit 4.
Measured: Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 20223 Jul 2023

First posted7 Dec 2021
Study start24 Jun 2022
Primary completion22 Jun 2023
Study completion3 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Inflammation Eye PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05147233
Sponsor's protocol ID: DX218
Acronym: OPTIMIZE-1
Status last verified: May 2025
First submitted: 24 Nov 2021
Last updated: 11 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 3
A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery
Postoperative Ocular Inflammation, Postoperative Ocular Pain
RecruitingPhase 4
Dextenza in the Post-op Management of Vitreoretinal Surgeries
Vitreoretinal Surgery, Ocular Inflammation
RecruitingPhase 2
Naturally Produced Cannabinoids for Neuroprotection From Concussion
Healthy
Recruiting
A Clinical Study to Determine What Effect the EyeCool Treatment Has on the Eye's Surface Anatomy and Inflammation Response After Being Treated for Having Chronic Ocular Surface Pain (COSP)
Eye Pain
Enrolling by invitation
EMDR for Persistent Pain in RA
Rheumatoid Arthritis

All Inflammation Eye Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery
ClinicalTrials.gov ID: NCT05147233
Acronym / sponsor ID: OPTIMIZE-1 / DX218
Conditions: Inflammation Eye Pain, Postoperative Cataract
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: OculisIndustry (pharma, biotech, devices)
Study start: 24 Jun 2022 (actual)
Primary completion: 22 Jun 2023 (actual)
Study completion: 3 Jul 2023 (actual)
First posted: 7 Dec 2021 (actual)
Results: Posted 11 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
OCS-01	Experimental	Drug: OCS-011 drop of OCS-01 (Dexamethasone ophthalmic suspension 1.5% [15 mg/mL]) in the study eye once daily (QD) for 14 days, beginning 1-day post-surgery in the study eye.
Vehicle	Placebo comparator	Drug: Vehicle1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye.
Have a pin-hole visual acuity (VA) without any other correction > 20 letters (approximately 20/400) in the operative eye and > 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 [prior to surgery]).

Key exclusion criteria (2 listed)

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.
Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OCS-01Dexamethasone ophthalmic suspension, 1.5%	Drug	OCS-01
VehicleVehicle	Drug	Vehicle

Primary outcome

Absence of Anterior Chamber Cells at Visit 6.
Time frame: Day 15
Absence of Ocular Pain at Visit 4.
Time frame: Day 4

Results and safety

Results posted to the registry on 11 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OCS-01	119	116
Vehicle	122	118

Primary outcome: Absence of Anterior Chamber Cells at Visit 6.

Time frame: Day 15. Number. Unit: percentage of study eyes

Measure	OCS-01 n = 119	Vehicle n = 122
Value	57.2	24.0

OCS-01 vs Vehicle: Difference in Percentages: 33.2 (95% CI 21.5 to 44.9), p <0.0001, Wald test

Population analysed: FAS

Primary outcome: Absence of Ocular Pain at Visit 4.

Time frame: Day 4. Number. Unit: percentage of study eyes

Measure	OCS-01 n = 119	Vehicle n = 122
Value	75.5	52.0

OCS-01 vs Vehicle: Difference in Percentages: 23.5 (95% CI 11.7 to 35.3), p <0.0001, Wald test

Population analysed: FAS

Adverse events

Time frame: From first dose until Day 90. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OCS-01	0 of 119 (0%)	2 of 119 (1.7%)	0 of 119
Vehicle	1 of 122 (0.8%)	8 of 122 (6.6%)	0 of 122

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Inflammation Eye Pain

Enrolling by invitationPhase 3
A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery
Postoperative Ocular Inflammation, Postoperative Ocular Pain
RecruitingPhase 4
Dextenza in the Post-op Management of Vitreoretinal Surgeries
Vitreoretinal Surgery, Ocular Inflammation
RecruitingPhase 2
Naturally Produced Cannabinoids for Neuroprotection From Concussion
Healthy
Recruiting
A Clinical Study to Determine What Effect the EyeCool Treatment Has on the Eye's Surface Anatomy and Inflammation Response After Being Treated for Having Chronic Ocular Surface Pain (COSP)
Eye Pain
Enrolling by invitation
EMDR for Persistent Pain in RA
Rheumatoid Arthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OCS-01 in people with Inflammation Eye Pain and Postoperative Cataract, run by Oculis at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of Anterior Chamber Cells at Visit 6. (time frame: Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05147233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.