Cataract
Conditions
Keywords
cataract surgery, Prophylaxis
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%.
Interventions
DRUGPred-Gati-Brom
The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%
DRUGPrednisolone acetate 1% ophthalmic suspension
Steroidal anti-inflammatory
DRUGGatifloxacin Ophthalmic
Antibiotic
DRUGBromfenac 0.075% Oph Solution
Non-steroidal anti-inflammatory
Sponsors
Science in Vision
Imprimis Pharmaceuticals, Inc.
Carolina Eyecare Physicians, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants' eyes are assigned to one of two groups.
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Preoperative Exam) in Macular Thickness | Month 1 | Thickness of the macula measured in microns, recorded as the change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) | Month 1 | Thickness of the cornea measured in microns, measured as the change from baseline |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075% | 33 |
| 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.
Pred-Gati-Brom: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075% | 33 |
| 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.
Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory
Gatifloxacin Ophthalmic: Antibiotic
Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory | 33 |
| 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.
Prednisolone acetate 1% ophthalmic suspension: Steroidal anti-inflammatory
Gatifloxacin Ophthalmic: Antibiotic
Bromfenac 0.075% Oph Solution: Non-steroidal anti-inflammatory | 33 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subjects did not comply with study protocol instructions. | 2 | 2 |
Baseline characteristics
| Characteristic | LessDrops | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 6.6 | 69.7 years STANDARD_DEVIATION 6.6 | 69.7 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 66 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 56 Participants | 28 Participants |
| Region of Enrollment United States | 33 participants | 33 participants | 33 participants |
| Sex: Female, Male Female | 18 Participants | 36 Participants | 18 Participants |
| Sex: Female, Male Male | 15 Participants | 30 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 2 / 33 | 6 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Change From Baseline (Preoperative Exam) in Macular Thickness
Thickness of the macula measured in microns, recorded as the change from baseline.
Time frame: Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LessDrops | Change From Baseline (Preoperative Exam) in Macular Thickness | 4.91 microns | Standard Deviation 8.46 |
| Standard of Care | Change From Baseline (Preoperative Exam) in Macular Thickness | 1.30 microns | Standard Deviation 4.13 |
Secondary
Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline
Time frame: Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LessDrops | Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) | -0.33 mmHg | Standard Deviation 3.35 |
| Standard of Care | Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) | -0.21 mmHg | Standard Deviation 3.37 |
Secondary
Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
Thickness of the cornea measured in microns, measured as the change from baseline
Time frame: Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LessDrops | Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) | 3.18 microns | Standard Deviation 20.46 |
| Standard of Care | Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) | 0.63 microns | Standard Deviation 18.37 |