Clinical trial NCT06128369: Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery
Official title: A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Ophthalmic Suspension in the Treatment of Inflammation and Pain Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Inflammation Eye
Pain, Postoperative
Cataract
Keywords: Ophthalmology
Topical Ophthalmic Solution
Eye Drop
Post-surgical
Lead sponsor: Oculis
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2023-11-13
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy and safety of OCS-01 in treating inflammation and pain in subjects following cataract surgery.

Detailed description: This is a multi-center, randomized, double-masked, vehicle-controlled study, designed to evaluate the efficacy and safety of OCS-01 compared to vehicle in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1 to receive OCS-01 or vehicle once daily.

Eligibility criteria: Inclusion Criteria (Selection):

* Provide written informed consent, approved by the appropriate ethics committee;
* Able to comply with the study requirements and visit schedule;
* At least 18 years of age of either sex or any race;
* Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
* Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \[18 to 30 hours post- uncomplicated cataract surgery without vitreous loss\]);

Exclusion Criteria:

* Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
* 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;
* Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye \*Additional inclusion/exclusion criteria apply

Primary outcomes:
measure: To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery
timeFrame: Visit 6 (Day 15)
measure: To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery
timeFrame: Visit 4 (Day 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: Oculis Investigative Site
state: California
city: Morrow
country: United States
facility: Oculis Investigative Site
state: Georgia
city: Louisville
country: United States
facility: Oculis Investigative Site
state: Kentucky
city: Saint Louis
country: United States
facility: Oculis Investigative Site
state: Missouri
city: Washington
country: United States
facility: Oculis Investigative Site
state: Missouri
city: Elizabeth City
country: United States
facility: Oculis Investigative Site
state: North Carolina
city: Eugene
country: United States
facility: Oculis Investigative Site
state: Oregon
city: Kingston
country: United States
facility: Oculis Investigative Site
state: Pennsylvania
city: Austin
country: United States
facility: Oculis Investigative Site
state: Texas
city: Houston
country: United States
facility: Oculis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Oculis Investigative Site
state: Texas
city: Lynchburg
country: United States
facility: Oculis Investigative Site
state: Virginia
Study officials:
References: