Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dropless vs. Standard Drops Contralateral Eye Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
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
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
Hide 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            
Arm/Group Title TriMoxiVanc One Eye + Control Fellow Eye TriMoxiVanc + Ilevro One Eye + Control Fellow Eye Total
Hide 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
Hide 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
1.Primary Outcome
Title Change From Baseline (Preoperative Exam) in Macular Thickness
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TriMoxiVanc TriMoxiVanc + Ilevro Control
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TriMoxiVanc TriMoxiVanc + Ilevro Control
Hide 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)
Time Frame Month 1.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TriMoxiVanc TriMoxiVanc + Ilevro Control
Hide 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)
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
Hide 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   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
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