Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery (OPTIMIZE-2)

Oculis

Status and phase: Terminated; Phase 3

Conditions: Cataract; Pain, Postoperative; Inflammation Eye

Treatments: Drug: Dexamethasone Ophthalmic Suspension; Other: Vehicle of OCS-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06128369

DX220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

117 participants in 2 patient groups, including a placebo group

OCS-01

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone Ophthalmic Suspension

Vehicle ophthalmic suspension

Placebo Comparator group

Description:

Vehicle of OCS-01

Treatment:

Other: Vehicle of OCS-01