Title
OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of Two Doses of OCS 01 Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery
Phase
Phase 2Lead Sponsor
OculisStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Inflammation Corneal Pain, PostoperativeIntervention/Treatment
OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL [dexamethasone (113195), cyclodextrin (87303)] ...Study Participants
153The DX-216 trial is a randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle in the treatment of inflammation and pain following cataract surgery. The primary objective is to evaluate the efficacy and safety of OCS-01 compared to placebo and the secondary objective is to evaluate the optimal dosing frequency (once a day [QD] or twice a day [BID]).
This is a multi-center, randomized, double-masked, placebo (vehicle)-controlled study, designed to evaluate the efficacy and safety of OCS-01 ophthalmic suspension (QD versus BID) compared to placebo in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1:1 to receive OCS-01 QD, OCS-01 BID, or placebo BID. Subjects will dose 1 drop in the study eye BID for 14 days, beginning 1 day post-surgery in the operated eye. The study will last up to 24 days, including a follow-up visit at Visit 7 (Day 22 ± 2).
OCS-01 eye drops
Vehicle eye drops
eye drops
eye drops
Inclusion Criteria: Provide written informed consent, approved by the appropriate ethics committee; Be able to comply with the study requirements and visit schedule; Be at least 18 years of age of either sex or any race; Be planning to 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]); 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]); Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 [prior to surgery]), Exclusion Criteria: Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components; Be 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; Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and other pain medications), or immunomodulating agents, systemically or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study.
| Event Type | Organ System | Event Term | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID |
|---|
Absence of pain as assessed by Ocular Pain Grading Scale (Min 0, Max 10) in which 0 is no pain and 10 is the worst possible. Outcome measure was the number of subjects who reported no pain
Absence of anterior chamber cells as measured by slit beam with fluoresceine The outcome measure was the number of subjects with an absence of anterior chamber cells
