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

Study Overview
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Brief Summary
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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]).

Detailed Description
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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).

Official Title
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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

Conditions
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Inflammation Corneal, Pain, Postoperative

Intervention / Treatment
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* Drug: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS-01 1.5% mg/mL QD<br>eye drops | Drug: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL<br>* OCS-01 eye drops<br>* Other names: DexNP;Drug: Placebo<br>* Vehicle eye drops<br>* Other names: Vehicle;|
| Experimental: OCS-01 1.5% mg/mL BID<br>eye drops | Drug: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL<br>* OCS-01 eye drops<br>* Other names: DexNP;|
| Placebo Comparator: Placebo (Vehicle) BID<br>eye drops | Drug: Placebo<br>* Vehicle eye drops<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0') | Absence of anterior chamber cells as measured by slit beam with fluorescein. The anterior chamber cell count was recorded as the actual number of cells observed if ≤10 cells were seen, otherwise a range was reported. The observed anterior chamber cell count at Visit 6 was used and categorized for analysis as follows: Absence of anterior chamber cells: anterior chamber cell count of 0 / Grade 0 Presence of anterior chamber cells: anterior chamber cell count of 1 or more / Grade 1, 2, 3, or 4 | at Day 15 (visit 6) | 
| Number of Subjects With Absence of Ocular Pain (i.e. Score of '0') | 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. Ocular pain was assessed by the patient at screening and at each follow-up visit, utilizing a numerical pain rating scale. Scores ranged from 0 to 10, where 0 = No Pain and 10 = Severe Pain, such that larger scores corresponded to higher levels of pain. | at Day 4 (visit 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-cataract,, inflammation, Pain, post-surgery, corticosteroid, anterior chamber cells, flares