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Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pred-Gati-Brom

Prednisolone acetate 1% ophthalmic suspension

Gatifloxacin Ophthalmic

Bromfenac 0.075% Oph Solution

About this trial

This is an interventional prevention trial for Cataract focused on measuring cataract surgery, Prophylaxis

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Carolina Eyecare Physicians, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

LessDrops

Standard of Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline (Preoperative Exam) in Macular Thickness

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

Secondary Outcome Measures

Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

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

Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

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

Full Information

NCT ID

NCT03578276

First Posted

June 19, 2018

Last Updated

June 9, 2022

Sponsor

Carolina Eyecare Physicians, LLC

Collaborators

Science in Vision, Imprimis Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03578276

Brief Title

Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

Official Title

Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

June 22, 2018 (Actual)

Primary Completion Date

December 4, 2019 (Actual)

Study Completion Date

December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Carolina Eyecare Physicians, LLC

Collaborators

Science in Vision, Imprimis Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

cataract surgery, Prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Participants' eyes are assigned to one of two groups.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LessDrops

Arm Type

Active Comparator

Arm Description

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pred-Gati-Brom

Other Intervention Name(s)

LessDrops

Intervention Description

The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%

Intervention Type

Drug

Intervention Name(s)

Prednisolone acetate 1% ophthalmic suspension

Intervention Description

Steroidal anti-inflammatory

Intervention Type

Drug

Intervention Name(s)

Gatifloxacin Ophthalmic

Intervention Description

Antibiotic

Intervention Type

Drug

Intervention Name(s)

Bromfenac 0.075% Oph Solution

Intervention Description

Non-steroidal anti-inflammatory

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

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

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerry Solomon, MD

Organizational Affiliation

Carolina Eyecare Physicians, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Carolina Eyecare Physicians, LLC

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

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