Trial Outcomes & Findings for Dropless vs. Standard Drops Contralateral Eye Study (NCT NCT02515045)
NCT ID: NCT02515045
Last Updated: 2018-02-23
Results Overview
Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Month 1.
Results posted on
2018-02-23
Participant Flow
Study recruitment started on December 2014 and ended in March 2016. Potential subjects were identified from the patients presenting at the clinics for eye evaluation.
No significant events in the study occurred after participant enrollment, but prior to randomization.
Unit of analysis: Eyes
Participant milestones
| Measure |
TriMoxiVanc
The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
|
TriMoxiVanc + Ilevro
Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
|
Control
Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29 29
|
30 30
|
59 59
|
|
Overall Study
COMPLETED
|
29 29
|
26 26
|
55 55
|
|
Overall Study
NOT COMPLETED
|
0 0
|
4 4
|
4 4
|
Reasons for withdrawal
| Measure |
TriMoxiVanc
The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
|
TriMoxiVanc + Ilevro
Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
|
Control
Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
Dropless vs. Standard Drops Contralateral Eye Study
Baseline characteristics by cohort
| Measure |
TriMoxiVanc One Eye + Control Fellow Eye
n=29 Participants
Subject's eyes were randomized to either TriMoxiVan or Control group.
TriMoxiVanc group:
Triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml used as an injection delivered into the vitreous cavity using a transzonular approach at the end of the uneventful phacoemulsification procedure after IOL implantation before removal of the OVD.
Control group:
Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.
Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
|
TriMoxiVanc + Ilevro One Eye + Control Fellow Eye
n=30 Participants
Subject's eyes were randomized to either TriMoxiVan + Ilevro or Control group.
TriMoxiVan + Ilevro group:
Nepafenac ophthalmic suspension 0.3% started 3 days prior to surgery QD and continued QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco (triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml ) injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
Control group:
Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued.
Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
69.3 Years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
68.5 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1.Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease.
Outcome measures
| Measure |
TriMoxiVanc
n=29 Participants
The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
|
TriMoxiVanc + Ilevro
n=26 Participants
Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
|
Control
n=55 Participants
Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
|
|---|---|---|---|
|
Change From Baseline (Preoperative Exam) in Macular Thickness
|
12.34 Microns
Standard Deviation 13.05
|
10.96 Microns
Standard Deviation 11.55
|
9.84 Microns
Standard Deviation 15.84
|
SECONDARY outcome
Timeframe: Month 1Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter. An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery.
Outcome measures
| Measure |
TriMoxiVanc
n=29 Participants
The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
|
TriMoxiVanc + Ilevro
n=26 Participants
Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
|
Control
n=55 Participants
Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
|
|---|---|---|---|
|
Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
|
14.44 Microns
Standard Deviation 13.95
|
5.94 Microns
Standard Deviation 14.07
|
4.47 Microns
Standard Deviation 15.63
|
SECONDARY outcome
Timeframe: Month 1.Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign.
Outcome measures
| Measure |
TriMoxiVanc
n=29 Participants
The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
|
TriMoxiVanc + Ilevro
n=26 Participants
Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
|
Control
n=55 Participants
Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
|
|---|---|---|---|
|
Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
|
-0.5 mmHg
Standard Deviation 2.8
|
-1.03 mmHg
Standard Deviation 3.3
|
-1.1 mmHg
Standard Deviation 3.0
|
Adverse Events
TriMoxiVanc
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TriMoxiVanc + Ilevro
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TriMoxiVanc
n=29 participants at risk
The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
|
TriMoxiVanc + Ilevro
n=26 participants at risk
Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.
TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
|
Control
n=55 participants at risk
Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
|
|---|---|---|---|
|
Eye disorders
Dry eyes
|
3.4%
1/29 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
0.00%
0/26 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
1.8%
1/55 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
|
Eye disorders
Rebound inflammation
|
0.00%
0/29 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
3.8%
1/26 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
3.6%
2/55 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
|
Eye disorders
Allergic conjuctivitis
|
0.00%
0/29 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
0.00%
0/26 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
1.8%
1/55 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
|
Eye disorders
Posterior vitreous detachments
|
3.4%
1/29 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
0.00%
0/26 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
1.8%
1/55 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
|
Eye disorders
Retinal detachment
|
3.4%
1/29 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
0.00%
0/26 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
0.00%
0/55 • In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
|
Additional Information
Helga P. Sandoval, MD, MSCR. Director of Research
Carolina Eyecare Physicians, LLC
Phone: 8438813937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place