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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

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ClinicalTrials.gov Identifier: NCT05147233
Recruitment Status : Not yet recruiting
First Posted : December 7, 2021
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Oculis

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.

Condition or disease Intervention/treatment Phase
Disorders of the Eye Following Cataract Surgery Drug: Dexamethasone Drug: Vehicle Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Active Treatment Arm
OCS-01 (Ophthalmic Suspension) - topical use
Drug: Dexamethasone
Dexamethasone
Other Name: OCS-01

Placebo Comparator: Vehicle Placebo Arm
Vehicle
Drug: Vehicle Placebo
Placebo comparator
Other Name: Placebo




Primary Outcome Measures :
  1. Number of Participants With an Absence of Anterior Chamber Inflammation [ Time Frame: Day 15 ]
    Absence of cells (i.e., score of ´0´) in the anterior chamber of the study eye at Day 15 (Visit 6)

  2. Number of Participants With an Absence of Ocular Pain [ Time Frame: Day 4 ]
    Absence of pain (i.e., score of ´0´) in the study eye at Day 4 (Visit 4)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147233


Contacts
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Contact: Naleni Eigensatz +41 21 711 3970 naleni.eigensatz@oculis.com

Locations
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United States, Texas
Oculis Investigative Site
Houston, Texas, United States, 77008
Sponsors and Collaborators
Oculis
Investigators
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Principal Investigator: Oculis Investigative Site Study Principal Investigator
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Responsible Party: Oculis
ClinicalTrials.gov Identifier: NCT05147233    
Other Study ID Numbers: DX218
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents