OPTIMIZE-2: Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery

Sponsor

Oculis (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06128369

Collaborator

ORA, Inc. (Industry)

160

Enrollment

Locations

Arms

Anticipated Duration (Months)

13.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Eye Pain, Postoperative Cataract	Drug: Dexamethasone Ophthalmic Suspension Other: Vehicle of OCS-01	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OCS-01 dexamethasone ophthalmic suspension,1.5% [15 mg/mL]	Drug: Dexamethasone Ophthalmic Suspension Ophthalmic Suspension,1.5% [15 mg/mL] Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1). Other Names: OCS-01
Placebo Comparator: Vehicle ophthalmic suspension Vehicle of OCS-01	Other: Vehicle of OCS-01 inert vehicle of OCS-01 ophthalmic suspension Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).

Arm

Intervention/Treatment

Experimental: OCS-01

dexamethasone ophthalmic suspension,1.5% [15 mg/mL]

Drug: Dexamethasone Ophthalmic Suspension

Ophthalmic Suspension,1.5% [15 mg/mL] Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).

Other Names:

OCS-01

Placebo Comparator: Vehicle ophthalmic suspension

Vehicle of OCS-01

Other: Vehicle of OCS-01

inert vehicle of OCS-01 ophthalmic suspension Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery [Visit 6 (Day 15)]
Absence of anterior chamber cells (i.e. score of '0')
To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery [Visit 4 (Day 4)]
Absence of pain (i.e. score of '0')

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oculis Investigative Site	Inglewood	California	United States	90301
2	Oculis Investigative Site	Morrow	Georgia	United States	30260
3	Oculis Investigative Site	Louisville	Kentucky	United States	40206
4	Oculis Investigative Site	Saint Louis	Missouri	United States	63131
5	Oculis Investigative Site	Washington	Missouri	United States	63090
6	Oculis Investigative Site	Elizabeth City	North Carolina	United States	27909
7	Oculis Investigative Site	Eugene	Oregon	United States	97401
8	Oculis Investigative Site	Kingston	Pennsylvania	United States	18704
9	Oculis Investigative Site	Austin	Texas	United States	78731
10	Oculis Investigative Site	Houston	Texas	United States	77008
11	Oculis Investigative Site	San Antonio	Texas	United States	78229
12	Oculis Investigative Site	Lynchburg	Virginia	United States	24502