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 (OPTIMIZE-1)

Oculis

Status and phase: Completed; Phase 3

Conditions: Inflammation Eye Pain; Postoperative Cataract

Treatments: Drug: Vehicle; Drug: OCS-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT05147233

DX218

Details and patient eligibility

About

This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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241 participants in 2 patient groups, including a placebo group

OCS-01

Experimental group

Description:

1 drop of OCS-01 (Dexamethasone ophthalmic suspension 1.5% \[15 mg/mL\]) in the study eye once daily (QD) for 14 days, beginning 1-day post-surgery in the study eye.

Treatment:

Drug: OCS-01

Vehicle

Placebo Comparator group

Description:

1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.

Treatment:

Drug: Vehicle