OCS-01 in Treating Inflammation and Pain in Post-cataract Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 \[BID\]).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06128369

Inflammation Eye Pain, Postoperative Cataract

TERMINATED PHASE3

A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery

NCT03687931

Inflammation Eye

COMPLETED PHASE1/PHASE2

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

NCT05147233

Inflammation Eye Pain Postoperative Cataract

COMPLETED PHASE3

Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

NCT01666210

Ocular Inflammation and Pain

COMPLETED PHASE2

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

NCT05626478

Corneal Edema Corneal Defect Anterior Chamber Inflammation +4 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation Corneal Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

For masking purposes, each dosing box and the pouches within it will be labeled either "AM" or "PM." Dosing boxes and pouches will be labeled this way regardless of whether the product within the 2 boxes is the same (i.e. OCS-01 BID and placebo treatment arms) or different (i.e. OCS-01 QD).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OCS-01 1.5% mg/mL QD

eye drops

Group Type EXPERIMENTAL

OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL

Intervention Type DRUG

OCS-01 eye drops

Placebo

Intervention Type DRUG

Vehicle eye drops

OCS-01 1.5% mg/mL BID

eye drops

Group Type EXPERIMENTAL

OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL

Intervention Type DRUG

OCS-01 eye drops

Placebo (Vehicle) BID

eye drops

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle eye drops

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL

OCS-01 eye drops

Intervention Type DRUG

Placebo

Vehicle eye drops

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DexNP Vehicle

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Provide written informed consent, approved by the appropriate ethics committee;
2. Be able to comply with the study requirements and visit schedule;
3. Be at least 18 years of age of either sex or any race;
4. Be planning to undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
5. Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \[18 to 30 hours post-uncomplicated cataract surgery without vitreous loss\]);
6. 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 \[prior to surgery\]);
7. Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 \[prior to surgery\]),

Exclusion Criteria

1. Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
2. Be monocular;
3. 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;
4. Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye;
5. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No