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

NCT04130802 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DX-216
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 4

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 \[BID\]).

Conditions

Inflammation Corneal; Pain, Postoperative

Keywords

post-cataract,; inflammation; Pain; post-surgery; corticosteroid; anterior chamber cells; flares

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

OCS-01 1.5% mg/mL QD

EXPERIMENTAL

eye drops

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

OCS-01 1.5% mg/mL BID

EXPERIMENTAL

eye drops

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

Placebo (Vehicle) BID

PLACEBO COMPARATOR

eye drops

Drug: Placebo

Interventions

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

OCS-01 eye drops

Also known as: DexNP

OCS-01 1.5% mg/mL BID; OCS-01 1.5% mg/mL QD

Placebo DRUG

Vehicle eye drops

Also known as: Vehicle

OCS-01 1.5% mg/mL QD; Placebo (Vehicle) BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[prior to surgery\]),

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oculis: lead

Study Sites (4)

Medical cennre

Petaluma, California, 94954, United States

Location

Medical center

Roseburg, Oregon, 97471, United States

Location

Medical center

Houston, Texas, 77008, United States

Location

Medical center

San Antonio, Texas, 78229, United States

Location

Related Publications (5)

• 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.

  PMID: 26201996 BACKGROUND

• 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.

  PMID: 21896859 BACKGROUND

• 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.

  PMID: 24373641 BACKGROUND

• 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.

  PMID: 16217662 BACKGROUND

• Korenfeld M, Gira J, Jong K, Martel J, Vold S, Walters T, Usner D, Donnenfeld E. OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized, Double-Masked, Vehicle-Controlled Study. Clin Ther. 2022 Dec;44(12):1577-1587. doi: 10.1016/j.clinthera.2022.11.003. Epub 2022 Dec 8.

  PMID: 36503736 DERIVED

MeSH Terms

Conditions

Keratitis; Pain, Postoperative; Inflammation; Pain

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Chief Development Officer
• Organization: Oculis SA

info@oculis.com

0041 21 711 39 70

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 17, 2019
• Study Start: September 27, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: September 10, 2025
• Results First Posted: March 15, 2022

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)