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

Pain, Postoperative Clinical Trial

— OPTIMIZE-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128369
• Other study ID #: DX220
• Status: Recruiting
• Phase: Phase 3
• Start date: December 18, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Oculis
• Contact: Oculis Study Leader
• Phone: +41 21 711 3970
• Email: info[@]oculis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Inflammation Eye
• Pain, Postoperative

Intervention

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:
• 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).

Locations

Country	Name	City	State
United States	Oculis Investigative Site	Austin	Texas
United States	Oculis Investigative Site	Elizabeth City	North Carolina
United States	Oculis Investigative Site	Eugene	Oregon
United States	Oculis Investigative Site	Houston	Texas
United States	Oculis Investigative Site	Inglewood	California
United States	Oculis Investigative Site	Kingston	Pennsylvania
United States	Oculis Investigative Site	Louisville	Kentucky
United States	Oculis Investigative Site	Lynchburg	Virginia
United States	Oculis Investigative Site	Morrow	Georgia
United States	Oculis Investigative Site	Saint Louis	Missouri
United States	Oculis Investigative Site	San Antonio	Texas
United States	Oculis Investigative Site	Washington	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Oculis	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery	Absence of anterior chamber cells (i.e. score of '0')	Visit 6 (Day 15)
Primary	To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery	Absence of pain (i.e. score of '0')	Visit 4 (Day 4)