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

Phase 2

Completed

• Conditions: Pain, Postoperative; Inflammation Corneal
• Interventions: Drug: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL; Drug: Placebo

• Registration Number: NCT04130802
• Lead Sponsor: Oculis

Brief Summary

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

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 Timeline

• Study Start: 2019-09-27
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-17
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-01
• Disposition First Submitted: 2021-01-13
• Disposition First Submitted QC: 2021-01-13
• Disposition First Posted: 2021-01-15
• Results First Submitted: 2022-02-17
• Results First Submitted QC: 2022-02-17
• Results First Posted: 2022-03-15
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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]),

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCS-01 1.5% mg/mL BID	OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL	eye drops
OCS-01 1.5% mg/mL QD	OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL	eye drops
OCS-01 1.5% mg/mL QD	Placebo	eye drops
Placebo (Vehicle) BID	Placebo	eye drops

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')	at Day 15 (visit 6)	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
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')	at Day 4 (visit 4)	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.

Trial Locations

Locations (2)

Medical cennre; 🇺🇸 Petaluma, California, United States

Medical center; 🇺🇸 San Antonio, Texas, United States