Dropless vs. Standard Drops Contralateral Eye Study

• ClinicalTrials.gov Identifier: NCT02515045
• Recruitment Status: Completed
• First Posted: August 4, 2015
• Results First Posted: August 22, 2017
• Last Update Posted: February 23, 2018
• Sponsor: Carolina Eyecare Physicians, LLC
• Collaborator: Science in Vision
• Information provided by (Responsible Party): Carolina Eyecare Physicians, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Cataract
• Interventions: Drug: TriMoxiVanc; Drug: Moxifloxacin HCl 0.5%; Drug: Ilevro; Drug: Prednisolone acetate 1%
• Enrollment: 59

Participant Flow

Recruitment Details	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.
Pre-assignment Details	No significant events in the study occurred after participant enrollment, but prior to randomization.

Arm/Group Title	TriMoxiVanc		TriMoxiVanc + Ilevro		Control
Arm/Group Description	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.		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.		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.
Period Title: Overall Study
	Number of participants	Number of units (Eyes)	Number of participants	Number of units (Eyes)	Number of participants	Number of units (Eyes)
Started	29	29	30	30	59	59
Completed	29	29	26	26	55	55
Not Completed	0	0	4	4	4	4
Reason Not Completed
Adverse Event	0		3		3
Lost to Follow-up	0		1		1

Baseline Characteristics

Arm/Group Title		TriMoxiVanc One Eye + Control Fellow Eye	TriMoxiVanc + Ilevro One Eye + Control Fellow Eye	Total
Arm/Group Description		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.	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 of all reporting groups
Overall Number of Baseline Participants		29	30	59
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	29 participants	30 participants	59 participants
		67.9 (7.5)	69.3 (6.8)	68.5 (7.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	30 participants	59 participants
	Female	21 72.4%	18 60.0%	39 66.1%
	Male	8 27.6%	12 40.0%	20 33.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	30 participants	59 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	29 100.0%	30 100.0%	59 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	29 participants	30 participants	59 participants
		29	30	59

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (Preoperative Exam) in Macular Thickness
Description	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.
Time Frame	Month 1.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	29	26	55
Mean (Standard Deviation); Unit of Measure: Microns
	12.34 (13.05)	10.96 (11.55)	9.84 (15.84)

2. Secondary Outcome

Title	Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
Description	Cornea 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.
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	29	26	55
Mean (Standard Deviation); Unit of Measure: Microns
	14.44 (13.95)	5.94 (14.07)	4.47 (15.63)

3. Secondary Outcome

Title	Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
Description	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.
Time Frame	Month 1.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	29	26	55
Mean (Standard Deviation); Unit of Measure: mmHg
	-0.5 (2.8)	-1.03 (3.3)	-1.1 (3.0)

Adverse Events

Time Frame	In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse Event Reporting Description	Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
Arm/Group Title	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
Arm/Group Description	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.	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.	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.
All-Cause Mortality
	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/29 (0.00%)	0/26 (0.00%)	0/55 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/29 (10.34%)	1/26 (3.85%)	5/55 (9.09%)
Eye disorders
Dry eyes	1/29 (3.45%)	0/26 (0.00%)	1/55 (1.82%)
Rebound inflammation	0/29 (0.00%)	1/26 (3.85%)	2/55 (3.64%)
Allergic conjuctivitis	0/29 (0.00%)	0/26 (0.00%)	1/55 (1.82%)
Posterior vitreous detachments	1/29 (3.45%)	0/26 (0.00%)	1/55 (1.82%)
Retinal detachment	1/29 (3.45%)	0/26 (0.00%)	0/55 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Helga P. Sandoval, MD, MSCR. Director of Research
• Organization: Carolina Eyecare Physicians, LLC
• Phone: 8438813937
• EMail: helga.sandoval@carolinaeyecare.com

• Responsible Party: Carolina Eyecare Physicians, LLC
• ClinicalTrials.gov Identifier: NCT02515045 History of Changes
• Other Study ID Numbers: CEP 14-002
• First Submitted: July 29, 2015
• First Posted: August 4, 2015
• Results First Submitted: July 24, 2017
• Results First Posted: August 22, 2017
• Last Update Posted: February 23, 2018