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

Pain, Postoperative Clinical Trial

— SKYGGN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130802
• Other study ID #: DX-216
• Status: Completed
• Phase: Phase 2
• Start date: September 27, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2021
• Source: Oculis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Inflammation Corneal
• Keratitis
• Pain, Postoperative

Intervention

Drug:
• OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
OCS-01 eye drops
• Placebo
Vehicle eye drops

Locations

Country	Name	City	State
United States	Medical center	Houston	Texas
United States	Medical cennre	Petaluma	California
United States	Medical center	Roseburg	Oregon
United States	Medical center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Oculis

Country where clinical trial is conducted

United States, 

References & Publications (4)

Johannesson G, Moya-Ortega MD, Asgrimsdottir GM, Lund SH, Thorsteinsdottir M, Loftsson T, Stefansson E. Kinetics of gamma-cyclodextrin nanoparticle suspension eye drops in tear fluid. Acta Ophthalmol. 2014 Sep;92(6):550-6. doi: 10.1111/aos.12334. Epub 2013 Dec 24. — View Citation

Ohira A, Hara K, Johannesson G, Tanito M, Asgrimsdottir GM, Lund SH, Loftsson T, Stefansson E. Topical dexamethasone gamma-cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema. Acta Ophthalmol. 2015 Nov;93(7):610-5. doi: 10.1111/aos.12803. Epub 2015 Jul 23. — View Citation

Saari KM, Nelimarkka L, Ahola V, Loftsson T, Stefansson E. Comparison of topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for postcataract inflammation. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):620-6. doi: 10.1007/s00417-005-0124-2. Epub 2005 Oct 11. — View Citation

Tanito M, Hara K, Takai Y, Matsuoka Y, Nishimura N, Jansook P, Loftsson T, Stefansson E, Ohira A. Topical dexamethasone-cyclodextrin microparticle eye drops for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7944-8. doi: 10.1167/iovs.11-8178. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)