A Phase 4 interventional study of Pred-Gati-Brom and Prednisolone acetate 1% ophthalmic suspension in Cataract, sponsored by Carolina Eyecare Physicians, LLC. Completed at 1 site in United States. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by Carolina Eyecare Physicians, LLC · Phase 4, Interventional, and Prevention
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.
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%.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 35 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Carolina Eyecare Physicians, LLC is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
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Exclusion Criteria:
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
* 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 · Drug: Gatifloxacin Ophthalmic · Drug: Bromfenac 0.075% Oph Solution
The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%
Also known as: LessDrops
Steroidal anti-inflammatory
Antibiotic
Non-steroidal anti-inflammatory
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
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
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
| Milestone | LessDrops | Standard of Care |
|---|---|---|
| Started | 35 | 35 |
| Completed | 33 | 33 |
| Not completed | 2 | 2 |
| Withdrew: Subjects did not comply with study protocol instructions. | 2 | 2 |
Thickness of the macula measured in microns, recorded as the change from baseline.
| microns | LessDrops | Standard of Care |
|---|---|---|
| Change From Baseline (Preoperative Exam) in Macular Thickness | 4.91 ± 8.46 | 1.30 ± 4.13 |
Thickness of the cornea measured in microns, measured as the change from baseline
| microns | LessDrops | Standard of Care |
|---|---|---|
| Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) | 3.18 ± 20.46 | 0.63 ± 18.37 |
Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline
| mmHg | LessDrops | Standard of Care |
|---|---|---|
| Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) | -0.33 ± 3.35 | -0.21 ± 3.37 |
Collected over One month. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LessDrops | 0/33 (0%) | 0/33 (0%) | 2/33 (6.1%) |
| Standard of Care | 0/33 (0%) | 0/33 (0%) | 6/33 (18.2%) |
| Event | LessDrops | Standard of Care |
|---|---|---|
| High intraocular pressureEye disorders | 1/33 | 2/33 |
| Rebound inflammationEye disorders | 1/33 | 2/33 |
| Macular edemaEye disorders | 0/33 | 1/33 |
| Punctate epithelial erosionsEye disorders | 0/33 | 1/33 |
33 subjects were enrolled, with 66 eyes. Subjects had one eye in each of the two arms.
| Age, Continuous(years) | LessDrops | Standard of Care | Total |
|---|---|---|---|
| Mean | 69.7 ± 6.6 | 69.7 ± 6.6 | 69.7 ± 6.6 |
| Sex: Female, Male(Participants) | LessDrops | Standard of Care | Total |
|---|---|---|---|
| Female | 18 | 18 | 36 |
| Male | 15 | 15 | 30 |
| Ethnicity (NIH/OMB)(Participants) | LessDrops | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 33 | 33 | 66 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LessDrops | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 28 | 28 | 56 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | LessDrops | Standard of Care | Total |
|---|---|---|---|
| United States | 33 | 33 | 33 |
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Carolina Eyecare Physicians, LLC