- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130802
OCS-01 in Treating Inflammation and Pain in Post-cataract Patients (SKYGGN)
January 13, 2023 updated by: Oculis
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
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]).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
153
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Petaluma, California, United States, 94954
- Medical cennre
-
-
Oregon
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Roseburg, Oregon, United States, 97471
- Medical Center
-
-
Texas
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Houston, Texas, United States, 77008
- Medical Center
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San Antonio, Texas, United States, 78229
- Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OCS-01 1.5% mg/mL QD
eye drops
|
OCS-01 eye drops
Other Names:
Vehicle eye drops
Other Names:
|
Experimental: OCS-01 1.5% mg/mL BID
eye drops
|
OCS-01 eye drops
Other Names:
|
Placebo Comparator: Placebo (Vehicle) BID
eye drops
|
Vehicle eye drops
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')
Time Frame: 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:
|
at Day 15 (visit 6)
|
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')
Time Frame: 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.
|
at Day 4 (visit 4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2019
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
October 16, 2019
First Submitted That Met QC Criteria
October 16, 2019
First Posted (Actual)
October 17, 2019
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Lens Diseases
- Corneal Diseases
- Pain, Postoperative
- Inflammation
- Cataract
- Keratitis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- DX-216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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