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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-18

Study Completion Date

2024-05-09

Brief Summary

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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

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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.

Conditions

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Inflammation Eye Pain, Postoperative Cataract

Keywords

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Ophthalmology Topical Ophthalmic Solution Eye Drop Post-surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OCS-01

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

Group Type EXPERIMENTAL

Dexamethasone Ophthalmic Suspension

Intervention Type DRUG

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).

Vehicle ophthalmic suspension

Vehicle of OCS-01

Group Type PLACEBO_COMPARATOR

Vehicle of OCS-01

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type OTHER

Other Intervention Names

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OCS-01

Eligibility Criteria

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Inclusion Criteria

* 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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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DX220

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

OCS-01

Dexamethasone Ophthalmic Suspension

Vehicle ophthalmic suspension

Vehicle of OCS-01

Interventions

Dexamethasone Ophthalmic Suspension

Vehicle of OCS-01

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

ORA, Inc.

Oculis

Responsible Party

Locations

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Oculis Investigative Site

Countries

Other Identifiers

DX220