FindTrial
Sign In

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02329743
Enrollment
256
Registered
2015-01-01
Start date
2014-12-31
Completion date
2015-09-30
Last updated
2019-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Inflammation, Pain

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.

Interventions

DRUGRX-10045

topical therapy

Sponsors

A.T. Resolve SARL
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Subjects With Clearing of Anterior InflammationDay 8score of zero for the Standardization of Uveitis Nomenclature scale

Secondary

MeasureTime frame
Proportion of Subjects Reporting no Ocular PainDay 3

Countries

United States

Participant flow

Participants by arm

ArmCount
RX-10045 0.05% Nanomicellar Solution
topical eye drops RX-10045: topical therapy
79
RX-10045 0.1% Nanomicellar Solution
topical eye drops RX-10045: topical therapy
79
Vehicle
topical eye drops RX-10045: topical therapy
78
Total236

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event113
Overall StudyLost to Follow-up101
Overall StudyOther023
Overall StudyWithdrawal by Subject441

Baseline characteristics

CharacteristicRX-10045 0.05% Nanomicellar SolutionRX-10045 0.1% Nanomicellar SolutionVehicleTotal
Age, Continuous67.3 years
STANDARD_DEVIATION 10.2
66.2 years
STANDARD_DEVIATION 8.6
66.1 years
STANDARD_DEVIATION 8.9
66.5 years
STANDARD_DEVIATION 9.2
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants11 Participants7 Participants30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
67 Participants68 Participants71 Participants206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants5 Participants8 Participants
Race (NIH/OMB)
Black or African American
7 Participants7 Participants6 Participants20 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants4 Participants5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants0 Participants4 Participants
Race (NIH/OMB)
White
67 Participants67 Participants63 Participants197 Participants
Sex: Female, Male
Female
42 Participants48 Participants48 Participants138 Participants
Sex: Female, Male
Male
37 Participants31 Participants30 Participants98 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 790 / 790 / 78
other
Total, other adverse events
0 / 790 / 790 / 78
serious
Total, serious adverse events
0 / 790 / 790 / 78

Outcome results

Primary

Proportion of Subjects With Clearing of Anterior Inflammation

score of zero for the Standardization of Uveitis Nomenclature scale

Time frame: Day 8

Population: ITT

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
RX-10045 0.05% Nanomicellar SolutionProportion of Subjects With Clearing of Anterior Inflammation18 Participants
RX-10045 0.1% Nanomicellar SolutionProportion of Subjects With Clearing of Anterior Inflammation18 Participants
VehicleProportion of Subjects With Clearing of Anterior Inflammation13 Participants
Secondary

Proportion of Subjects Reporting no Ocular Pain

Time frame: Day 3

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
RX-10045 0.05% Nanomicellar SolutionProportion of Subjects Reporting no Ocular Pain25 Participants
RX-10045 0.1% Nanomicellar SolutionProportion of Subjects Reporting no Ocular Pain21 Participants
VehicleProportion of Subjects Reporting no Ocular Pain33 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026