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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Disorders of the Eye Following Cataract Surgery | Drug: Dexamethasone Drug: Vehicle Placebo | Phase 3 |
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| Study Type : | Interventional (Clinical Trial) |
| EstimatedEnrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | OCS-01: A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery |
| Actual Study Start Date : | June 1, 2022 |
| Estimated Primary Completion Date : | March 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine 
MedlinePlus related topics: Cataract
Drug Information available for: Dexamethasone
U.S. FDA Resources
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| Arm | Intervention/treatment |
|---|---|
| Experimental: Active Treatment Arm OCS-01 (Ophthalmic Suspension) - topical use | Drug: Dexamethasone Dexamethasone Other Name: OCS-01 |
| Placebo Comparator: Vehicle Placebo Arm Vehicle | Drug: Vehicle Placebo Placebo comparator Other Name: Placebo |
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Primary Outcome Measures :
- Number of Participants With an Absence of Anterior Chamber Inflammation [TimeFrame:Day 15]
Absence of cells (i.e., score of ´0´) in the anterior chamber of the study eye at Day 15 (Visit 6)
- Number of Participants With an Absence of Ocular Pain [TimeFrame:Day 4]
Absence of pain (i.e., score of ´0´) in the study eye at Day 4 (Visit 4)
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye;
- 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]).
Exclusion Criteria:
- 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.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147233
Contacts
| Contact: Bastian Dehmel, MD | +41 21 711 3970 | bastian.dehmel@oculis.com |
Locations
| United States, Texas | |
| Oculis Investigative Site | Recruiting |
| Houston, Texas, United States, 77008 | |
| Contact: Kevin Jong, MD kjong@houstoneye.com | |
Sponsors and Collaborators
Oculis
Investigators
| Principal Investigator: | Oculis Investigative Site | Study Principal Investigator |
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| Responsible Party: | Oculis |
| ClinicalTrials.gov Identifier: | NCT05147233 |
| Other Study ID Numbers: | DX218 |
| First Posted: | December 7, 2021 Key Record Dates |
| Last Update Posted: | January 11, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Cataract Inflammation Pathologic Processes Lens Diseases Eye Diseases Dexamethasone Anti-Inflammatory Agents Antiemetics Autonomic Agents | Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
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