Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen
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ClinicalTrials.gov Identifier: NCT03578276 |
Recruitment Status :
Completed
First Posted : July 6, 2018
Last Update Posted : January 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cataract | Drug: Pred-Gati-Brom Drug: Prednisolone acetate 1% ophthalmic suspension Drug: Gatifloxacin Ophthalmic Drug: Bromfenac 0.075% Oph Solution | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | December 4, 2019 |
Actual Study Completion Date : | December 4, 2019 |
Arm | Intervention/treatment |
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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.
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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
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Drug: Prednisolone acetate 1% ophthalmic suspension
Steroidal anti-inflammatory Drug: Gatifloxacin Ophthalmic Antibiotic Drug: Bromfenac 0.075% Oph Solution Non-steroidal anti-inflammatory |
- Change From Baseline (Preoperative Exam) in Macular Thickness [ Time Frame: Month 1 ]Thickness of the macula measured in microns
- Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) [ Time Frame: Month 1 ]Thickness of the cornea measured in microns
- Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) [ Time Frame: Month 1 ]Measurement of the pressure inside the eye in mmHg

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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 |
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.

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
United States, South Carolina | |
Carolina Eyecare Physicians, LLC | |
Mount Pleasant, South Carolina, United States, 29464 |
Principal Investigator: | Kerry Solomon, MD | Carolina Eyecare Physicians, LLC |
Responsible Party: | Carolina Eyecare Physicians, LLC |
ClinicalTrials.gov Identifier: | NCT03578276 |
Other Study ID Numbers: |
CEP 2016-001 |
First Posted: | July 6, 2018 Key Record Dates |
Last Update Posted: | January 23, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
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 |
cataract surgery Prophylaxis |
Cataract Lens Diseases Eye Diseases Gatifloxacin Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Bromfenac Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents 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 |