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

NCT06128369 | Terminated Phase 3 FDA Drug

• 1 other identifier: DX220
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 12

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.

Conditions

Inflammation Eye; Pain, Postoperative; Cataract

Keywords

Ophthalmology; Topical Ophthalmic Solution; Eye Drop; Post-surgical

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

OCS-01

EXPERIMENTAL

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

Drug: Dexamethasone Ophthalmic Suspension

Vehicle ophthalmic suspension

PLACEBO COMPARATOR

Vehicle of OCS-01

Other: Vehicle of OCS-01

Interventions

Dexamethasone Ophthalmic Suspension 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).

Also known as: OCS-01

OCS-01

Vehicle of OCS-01 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).

Vehicle ophthalmic suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[18 to 30 hours post- uncomplicated cataract surgery without vitreous loss\]);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Oculis: lead
• ORA, Inc.: collaborator

Study Sites (12)

Oculis Investigative Site

Inglewood, California, 90301, United States

Location

Oculis Investigative Site

Morrow, Georgia, 30260, United States

Location

Oculis Investigative Site

Louisville, Kentucky, 40206, United States

Location

Oculis Investigative Site

St Louis, Missouri, 63131, United States

Location

Oculis Investigative Site

Washington, Missouri, 63090, United States

Location

Oculis Investigative Site

Elizabeth City, North Carolina, 27909, United States

Location

Oculis Investigative Site

Eugene, Oregon, 97401, United States

Location

Oculis Investigative Site

Kingston, Pennsylvania, 18704, United States

Location

Oculis Investigative Site

Austin, Texas, 78731, United States

Location

Oculis Investigative Site

Houston, Texas, 77008, United States

Location

Oculis Investigative Site

San Antonio, Texas, 78229, United States

Location

Oculis Investigative Site

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Endophthalmitis; Pain, Postoperative; Cataract

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Lens Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 18, 2023
• Primary Completion: May 2, 2024
• Study Completion: May 9, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)