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Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

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ClinicalTrials.gov Identifier: NCT03578276
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
Science in Vision
Imprimis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Carolina Eyecare Physicians, LLC

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : June 22, 2018
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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 Name: LessDrops
Active Comparator: Standard of Care
  • 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.
 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
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Primary Outcome Measures :
  1. Change From Baseline (Preoperative Exam) in Macular Thickness [ Time Frame: Month 1 ]
    Thickness of the macula measured in microns


Secondary Outcome Measures :
  1. Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) [ Time Frame: Month 1 ]
    Thickness of the cornea measured in microns

  2. Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) [ Time Frame: Day 1, Day 15 and Day 30. ]
    Measurement of the pressure inside the eye in mmHg


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578276


Contacts
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Contact: Helga P Sandoval 8438813937 helga.sandoval@carolinaeyecare.com

Locations
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United States, South Carolina
Carolina Eyecare Physicians, LLC Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Helga P Sandoval, MD, MSCR    843-881-3937    helga.sandoval@carolinaeyecare.com   
Principal Investigator: Kerry D Solomon, MD         
Sub-Investigator: Jefrrey F Hood, OD         
Sponsors and Collaborators
Carolina Eyecare Physicians, LLC
Science in Vision
Imprimis Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Kerry Solomon, MD Carolina Eyecare Physicians, LLC
More Information
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Responsible Party: Carolina Eyecare Physicians, LLC
ClinicalTrials.gov Identifier: NCT03578276     History of Changes
Other Study ID Numbers: CEP 2016-001
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cataract
Lens Diseases
Eye Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Bromfenac
Anti-Inflammatory Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Gatifloxacin
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents