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

Disorders of the Eye Following Cataract Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05147233
• Other study ID #: DX218
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: Oculis
• Contact: Bastian Dehmel, MD
• Phone: +41 21 711 3970
• Email: bastian.dehmel[@]oculis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Disorders of the Eye Following Cataract Surgery
• Inflammation

Intervention

Drug:
• Dexamethasone
Dexamethasone
• Vehicle Placebo
Placebo comparator

Locations

Country	Name	City	State
United States	Oculis Investigative Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Oculis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 15
Primary	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)	Day 4