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A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687931
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
iDrop, Inc.

Study Description
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Brief Summary:
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.

Condition or disease Intervention/treatment Phase
Inflammation Eye Drug: Dexamethasone Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery
Actual Study Start Date : August 26, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Dexamethasone suspension dose level 1
 Drug: Dexamethasone
Drop
Experimental: Arm 2
Dexamethasone suspension dose level 2
 Drug: Dexamethasone
Drop


Outcome Measures
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Primary Outcome Measures :
  1. Anterior Chamber Cell [ Time Frame: 30 days ]
    Number of cells in the anterior chamber


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

Exclusion Criteria:

  • Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
  • Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
  • Patients who are known steroid responders
Contacts and Locations
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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): NCT03687931


Locations
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United States, Arizona
Arizona Eye Center
Chandler, Arizona, United States, 85224
Sponsors and Collaborators
iDrop, Inc.
Investigators
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Study Chair: William White iDrop, Inc.
More Information
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Responsible Party: iDrop, Inc.
ClinicalTrials.gov Identifier: NCT03687931    
Other Study ID Numbers: C-01
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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