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Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in 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: NCT02329743
Recruitment Status : Completed
First Posted : January 1, 2015
Results First Posted : February 5, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
A.T. Resolve SARL

Brief Summary:
The primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.

Condition or disease Intervention/treatment Phase
Inflammation Pain Cataract Drug: RX-10045 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Masked, Parallel-Group, Vehicle-Controlled Study to Assess the Efficacy and Safety of RX-10045 Nanomicellar Ophthalmic Solution for Treatment of Ocular Inflammation and Pain in Subjects Undergoing Cataract Surgery
Study Start Date : December 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: RX-10045 0.05% nanomicellar solution
topical eye drops
Drug: RX-10045
topical therapy

Experimental: RX-10045 0.1% nanomicellar solution
topical eye drops
Drug: RX-10045
topical therapy

Placebo Comparator: Vehicle
topical eye drops
Drug: RX-10045
topical therapy




Primary Outcome Measures :
  1. Proportion of Subjects With Clearing of Anterior Inflammation [ Time Frame: Day 8 ]
    score of zero for the Standardization of Uveitis Nomenclature scale


Secondary Outcome Measures :
  1. Proportion of Subjects Reporting no Ocular Pain [ Time Frame: Day 3 ]


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag.

Exclusion Criteria:

  • Any additional surgical procedures at the time of the cataract surgery
  • Refractive surgery in the study eye within the past 2 years
  • History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis, scleritis, uveitis) in either eye
  • Intraocular pressure of > 21 mm Hg in either eye
  • Proliferative or severe nonproliferative diabetic retinopathy in either eye
  • Neovascular/wet age-related macular degeneration in either eye

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): NCT02329743


Locations
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United States, New Jersey
Auven Therapeutics
Murray Hill, New Jersey, United States, 07974
Sponsors and Collaborators
A.T. Resolve SARL
Investigators
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Study Director: Tomasz Sablinski, MD Auven Therapeutics
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Responsible Party: A.T. Resolve SARL
ClinicalTrials.gov Identifier: NCT02329743    
Other Study ID Numbers: ATR-45-1401
First Posted: January 1, 2015    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: February 20, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Cataract
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases