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Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery

Primary Purpose

Inflammation, Pain, Cataract

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RX-10045
Sponsored by
A.T. Resolve SARL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Auven Therapeutics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RX-10045 0.05% nanomicellar solution

RX-10045 0.1% nanomicellar solution

Vehicle

Arm Description

topical eye drops

topical eye drops

topical eye drops

Outcomes

Primary Outcome Measures

Proportion of Subjects With Clearing of Anterior Inflammation
score of zero for the Standardization of Uveitis Nomenclature scale

Secondary Outcome Measures

Proportion of Subjects Reporting no Ocular Pain

Full Information

First Posted
December 23, 2014
Last Updated
February 4, 2019
Sponsor
A.T. Resolve SARL
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1. Study Identification

Unique Protocol Identification Number
NCT02329743
Brief Title
Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A.T. Resolve SARL

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Pain, Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RX-10045 0.05% nanomicellar solution
Arm Type
Experimental
Arm Description
topical eye drops
Arm Title
RX-10045 0.1% nanomicellar solution
Arm Type
Experimental
Arm Description
topical eye drops
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
topical eye drops
Intervention Type
Drug
Intervention Name(s)
RX-10045
Intervention Description
topical therapy
Primary Outcome Measure Information:
Title
Proportion of Subjects With Clearing of Anterior Inflammation
Description
score of zero for the Standardization of Uveitis Nomenclature scale
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Proportion of Subjects Reporting no Ocular Pain
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Sablinski, MD
Organizational Affiliation
Auven Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Auven Therapeutics
City
Murray Hill
State/Province
New Jersey
ZIP/Postal Code
07974
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery

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