Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

• Sponsor: Carolina Eyecare Physicians, LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT03578276
• Collaborator: Science in Vision (Other), Imprimis Pharmaceuticals, Inc. (Industry)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.4
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

To compare the use of a compounded eye drop containing an antibiotic, a non-steroidal and steroidal anti-inflammatory to standard of care that is the use of 3 different topical medications to prevent inflammation and infection after routine cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Pred-Gati-Brom; Drug: Prednisolone acetate 1% ophthalmic suspension; Drug: Gatifloxacin Ophthalmic; Drug: Bromfenac 0.075% Oph Solution	Phase 4

Detailed Description

Cataract surgery is one of the most commonly performed surgeries in the world today. To improve the overall procedure outcome, prophylactic topical antibiotics and anti-inflammatories (steroidal and non-steroidal, NSAID) are frequently used to decrease the risk of postoperative infection (e.g., endophthalmitis) and intraocular inflammation (e.g., macular edema, CME).

Even though, the large body of literature that supports the significance of prophylactic eye drops prior to surgery, patient compliance is a common problem. Different factors have been associated with patient's lack of compliance. It could be due to patient's inability to self- administer the drops, lack of understanding of the importance of using the prophylactic treatment as well as understanding the instructions of how to administer the drops and its storage, or just forgetfulness or the fact that they don't like to put the drops multiple times a day for 2-4 weeks, therefore they just avoid doing it. About 64% of patients adhere to the prescribed treatment.

There is a new alternative that combines the most commonly used antibiotic and anti-inflammatories into a single drop. The use of a single drop compounded ophthalmic solution may offer advantages such as increased compliance, patient comfort and reduced ocular toxicity. T

The purpose of this study is to compare the Pred-Gati-Brom formulation to the standard topical drops regimen that includes the topical use of Gatifloxacin, Bromfenac and Prednisolone acetate 1%.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants' eyes are assigned to one of two groups.Participants' eyes are assigned to one of two groups.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen
• Actual Study Start Date: Jun 22, 2018
• Actual Primary Completion Date: Dec 4, 2019
• Actual Study Completion Date: Dec 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LessDrops Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week.	Drug: Pred-Gati-Brom; The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%; Other Names: LessDrops
Active Comparator: Standard of Care Gatifloxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue.	Drug: Prednisolone acetate 1% ophthalmic suspension; Steroidal anti-inflammatory; Drug: Gatifloxacin Ophthalmic; Antibiotic; Drug: Bromfenac 0.075% Oph Solution; Non-steroidal anti-inflammatory

Outcome Measures

Primary Outcome Measures

1. Change From Baseline (Preoperative Exam) in Macular Thickness [Month 1]

   Thickness of the macula measured in microns, recorded as the change from baseline.

Secondary Outcome Measures

1. Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) [Month 1]

   Thickness of the cornea measured in microns, measured as the change from baseline

2. Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) [Month 1]

   Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation.

• Willing and able to provide written informed consent for participation in the study.

• Willing and able to comply with scheduled visits and other study procedures.

• Willing and able to administer eye drops and record the times the drops were instilled.

• Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.

• Potential postoperative best-corrected visual acuity of 20/30 or better.

Exclusion Criteria:

• Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, advanced macular degeneration, advanced glaucomatous damage, etc.

• Uncontrolled diabetes.

• Use of any systemic or topical drug known to interfere with visual performance.

• Contact lens use during the active treatment portion of the trial.

• Any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis.

• History of chronic intraocular inflammation.

• History of retinal detachment.

• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.

• Any additional ocular surgical procedures at time of cataract extraction (i.e. iStent) except corneal incisions for the correction of astigmatism.

• Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).

• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.

• Participation in (or current participation) any ophthalmic investigational drug or device trial within the previous 30 days prior to the start date of this trial.

• Intraocular conventional surgery within the past three months or intraocular laser surgery within one month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina	United States	29464

Sponsors and Collaborators

• Carolina Eyecare Physicians, LLC
• Science in Vision
• Imprimis Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Kerry Solomon, MD, Carolina Eyecare Physicians, LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2017

More Information

Publications

None provided.

• Responsible Party: Carolina Eyecare Physicians, LLC
• ClinicalTrials.gov Identifier: NCT03578276
• Other Study ID Numbers: CEP 2016-001
• First Posted: Jul 6, 2018
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Carolina Eyecare Physicians, LLC: cataract surgery; Prophylaxis
• Additional relevant MeSH terms: Cataract; Gatifloxacin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Bromfenac; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	LessDrops	Standard of Care
Arm/Group Description	Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week. Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%	Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue. Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory Gatifloxacin Ophthalmic: Antibiotic Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory
Period Title: Overall Study
STARTED	35	35
COMPLETED	33	33
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	LessDrops	Standard of Care	Total
Arm/Group Description	Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week. Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%	Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue. Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory Gatifloxacin Ophthalmic: Antibiotic Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory	Total of all reporting groups
Overall Participants	33	33	33
Overall Eyes	33	33	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.7 (6.6)	69.7 (6.6)	69.7 (6.6)
Sex: Female, Male (Count of Participants)
Female	18 54.5%	18 54.5%	36 109.1%
Male	15 45.5%	15 45.5%	30 90.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	33 100%	33 100%	66 200%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 15.2%	5 15.2%	10 30.3%
White	28 84.8%	28 84.8%	56 169.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	33 100%	33 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (Preoperative Exam) in Macular Thickness
Description	Thickness of the macula measured in microns, recorded as the change from baseline.
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LessDrops	Standard of Care
Arm/Group Description	Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week. Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%	Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue. Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory Gatifloxacin Ophthalmic: Antibiotic Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory
Measure Participants	33	33
Measure eyes	33	33
Mean (Standard Deviation) [microns]	4.91 (8.46)	1.30 (4.13)

2. Secondary Outcome

Title	Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
Description	Thickness of the cornea measured in microns, measured as the change from baseline
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LessDrops	Standard of Care
Arm/Group Description	Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week. Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%	Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue. Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory Gatifloxacin Ophthalmic: Antibiotic Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory
Measure Participants	33	33
Measure Eyes	33	33
Mean (Standard Deviation) [microns]	3.18 (20.46)	0.63 (18.37)

3. Secondary Outcome

Title	Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
Description	Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LessDrops	Standard of Care
Arm/Group Description	Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week. Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%	Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue. Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory Gatifloxacin Ophthalmic: Antibiotic Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory
Measure Participants	33	33
Measure eyes	33	33
Mean (Standard Deviation) [mmHg]	-0.33 (3.35)	-0.21 (3.37)

Adverse Events

Time Frame	One month
Arm/Group Title	LessDrops		Standard of Care
Arm/Group Description	Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week. Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%		Gatifoxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue. Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory Gatifloxacin Ophthalmic: Antibiotic Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory
All Cause Mortality
	LessDrops		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Serious Adverse Events
	LessDrops		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	LessDrops		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/33 (6.1%)		6/33 (18.2%)
Eye disorders
High intraocular pressure	1/33 (3%)		2/33 (6.1%)
Rebound inflammation	1/33 (3%)		2/33 (6.1%)
Macular edema	0/33 (0%)		1/33 (3%)
Punctate epithelial erosions	0/33 (0%)		1/33 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.