NCT05147233

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

June 24, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 11, 2025

Completed
Last Updated

July 11, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

November 24, 2021

Results QC Date

June 24, 2025

Last Update Submit

June 24, 2025

Conditions

Inflammation Eye PainPostoperative Cataract

Outcome Measures

Primary Outcomes (2)

  • Absence of Anterior Chamber Cells at Visit 6.

    Day 15

  • Absence of Ocular Pain at Visit 4.

    Day 4

Study Arms (2)

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.

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.

Drug: Vehicle

Interventions

OCS-01DRUG

Dexamethasone ophthalmic suspension, 1.5%

OCS-01
VehicleDRUG

Vehicle

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[prior to surgery\]).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Oculis Site 16

Chandler, Arizona, 85224, United States

Location

Oculis Site 28

Phoenix, Arizona, 85003, United States

Location

Oculis Site 8

Fayetteville, Arkansas, 72704, United States

Location

Oculis Site 9

Inglewood, California, 90301, United States

Location

Oculis Site 23

Newport Beach, California, 92663, United States

Location

Oculis Site 26

Petaluma, California, 94954, United States

Location

Oculis Site 24

San Pedro, California, 90731, United States

Location

Oculis Site 22

Westminster, California, 92683, United States

Location

Oculis Site 11

Fort Collins, Colorado, 80528, United States

Location

Oculis Site 12

Tamarac, Florida, 33321, United States

Location

Oculis Site 17

Morrow, Georgia, 30260, United States

Location

Oculis Site 20

Louisville, Kentucky, 40206, United States

Location

Oculis Site 5

St Louis, Missouri, 63128, United States

Location

Oculis Site 3

Washington, Missouri, 63090, United States

Location

Oculis Site 13

Kinston, North Carolina, 28501, United States

Location

Oculis Site 6

Brecksville, Ohio, 44141, United States

Location

Oculis Site 14

Cincinnati, Ohio, 45242, United States

Location

Oculis Site 25

Eugene, Oregon, 97401, United States

Location

Oculis Site 7

Kingston, Pennsylvania, 18704, United States

Location

Oculis Site 4

Austin, Texas, 78731, United States

Location

Oculis Site 10

Houston, Texas, 77025, United States

Location

Oculis Site 2

San Antonio, Texas, 78229, United States

Location

Oculis Site 31

San Antonio, Texas, 78229, United States

Location

Oculis Site 27

Salt Lake City, Utah, 84032, United States

Location

Oculis Site 30

Lynchburg, Virginia, 24502, United States

Location

Results Point of Contact

Title
Sharon Klier, M.D., M.S., M.P.H, Chief Development Officer
Organization
OCULIS Operations SàrI
info@oculis.com
+41 21 711 3970

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 7, 2021

Study Start

June 24, 2022

Primary Completion

June 22, 2023

Study Completion

July 3, 2023

Last Updated

July 11, 2025

Results First Posted

July 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(25)