Back to resultsOCS-01: 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
Primary Purpose
Disorders of the Eye Following Cataract Surgery
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Vehicle Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Disorders of the Eye Following Cataract Surgery
Eligibility Criteria
Inclusion Criteria:
- 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]).
Exclusion Criteria:
- 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.
Sites / Locations
- Oculis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Treatment Arm
Vehicle Placebo Arm
Arm Description
OCS-01 (Ophthalmic Suspension) - topical use
Vehicle
Outcomes
Primary Outcome Measures
Number of Participants With an Absence of Anterior Chamber Inflammation
Absence of cells (i.e., score of ´0´) in the anterior chamber of the study eye at Day 15 (Visit 6)
Number of Participants With an Absence of Ocular Pain
Absence of pain (i.e., score of ´0´) in the study eye at Day 4 (Visit 4)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05147233
Brief Title
OCS-01: 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
Official Title
OCS-01: 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorders of the Eye Following Cataract Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment Arm
Arm Type
Experimental
Arm Description
OCS-01 (Ophthalmic Suspension) - topical use
Arm Title
Vehicle Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
OCS-01
Intervention Description
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Vehicle Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Number of Participants With an Absence of Anterior Chamber Inflammation
Description
Absence of cells (i.e., score of ´0´) in the anterior chamber of the study eye at Day 15 (Visit 6)
Time Frame
Day 15
Title
Number of Participants With an Absence of Ocular Pain
Description
Absence of pain (i.e., score of ´0´) in the study eye at Day 4 (Visit 4)
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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]).
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bastian Dehmel, MD
Phone
+41 21 711 3970
Email
bastian.dehmel@oculis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oculis Investigative Site
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oculis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Jong, MD
Email
kjong@houstoneye.com
12. IPD Sharing Statement
Learn more about this trial
OCS-01: 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
We'll reach out to this number within 24 hrs