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 2
  • Study Type

    Interventional
  • Study Participants

    153
The 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).
Study Started
Sep 27
2019
Primary Completion
Jan 31
2020
Study Completion
Jan 31
2020
Results Posted
Mar 15
2022
Last Update
Mar 15
2022

Drug OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL [dexamethasone, cyclodextrin]

OCS-01 eye drops

  • Other names: DexNP

Drug Placebo

Vehicle eye drops

  • Other names: Vehicle

Placebo (Vehicle) BID Placebo Comparator

eye drops

Criteria

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.

Summary

OCS-01 1.5% mg/mL QD

OCS-01 1.5% mg/mL BID

Placebo (Vehicle) BID

All Events

Event Type Organ System Event Term OCS-01 1.5% mg/mL QD OCS-01 1.5% mg/mL BID Placebo (Vehicle) BID

Ocular Pain

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

OCS-01 1.5% mg/mL QD

37.0
number of subjects with no pain

OCS-01 1.5% mg/mL BID

32.0
number of subjects with no pain

Placebo (Vehicle) BID

23.0
number of subjects with no pain

Anterior Chamber Cells

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

OCS-01 1.5% mg/mL QD

26.0
Number of subjects with no cells

OCS-01 1.5% mg/mL BID

34.0
Number of subjects with no cells

Placebo (Vehicle) BID

10.0
Number of subjects with no cells

Total

153
Participants

Age, Continuous

67.1
years (Mean)
Standard Deviation: 7.34

Age, Categorical

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

OCS-01 1.5% mg/mL QD

OCS-01 1.5% mg/mL BID

Placebo (Vehicle) BID