Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
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
1 other identifier
interventional
256
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
February 5, 2019
CompletedFebruary 20, 2019
February 1, 2019
9 months
December 23, 2014
January 11, 2019
February 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects With Clearing of Anterior Inflammation
score of zero for the Standardization of Uveitis Nomenclature scale
Day 8
Secondary Outcomes (1)
Proportion of Subjects Reporting no Ocular Pain
Day 3
Study Arms (3)
RX-10045 0.05% nanomicellar solution
EXPERIMENTALtopical eye drops
RX-10045 0.1% nanomicellar solution
EXPERIMENTALtopical eye drops
Vehicle
PLACEBO COMPARATORtopical eye drops
Interventions
topical therapy
Eligibility Criteria
You may qualify if:
- Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Auven Therapeutics
Murray Hill, New Jersey, 07974, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- S Weiss
- Organization
- Auven Therapeutics
Study Officials
- STUDY DIRECTOR
Tomasz Sablinski, MD
Auven Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2014
First Posted
January 1, 2015
Study Start
December 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
February 20, 2019
Results First Posted
February 5, 2019
Record last verified: 2019-02