Trial Outcomes & Findings for Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen (NCT NCT03578276)
NCT ID: NCT03578276
Last Updated: 2022-06-10
Results Overview
Thickness of the macula measured in microns, recorded as the change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
Month 1
Results posted on
2022-06-10
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
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%
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
35 35
|
35 35
|
|
Overall Study
COMPLETED
|
33 33
|
33 33
|
|
Overall Study
NOT COMPLETED
|
2 2
|
2 2
|
Reasons for withdrawal
| Measure |
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%
|
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
|
|---|---|---|
|
Overall Study
Subjects did not comply with study protocol instructions.
|
2
|
2
|
Baseline Characteristics
A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
Baseline characteristics by cohort
| Measure |
LessDrops
n=33 Eyes
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%
|
Standard of Care
n=33 Eyes
* 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
|
Total
n=66 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
69.7 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=7 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=7 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=7 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
5 Participants
n=7 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
10 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
28 Participants
n=7 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
56 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=7 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=7 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
0 Participants
n=5 Participants • A total of 35 subjects signed the informed consent and who met the inclusion/exclusion criteria were successfully enrolled in the study.
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1Thickness of the macula measured in microns, recorded as the change from baseline.
Outcome measures
| Measure |
LessDrops
n=33 eyes
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%
|
Standard of Care
n=33 eyes
* 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
|
|---|---|---|
|
Change From Baseline (Preoperative Exam) in Macular Thickness
|
4.91 microns
Standard Deviation 8.46
|
1.30 microns
Standard Deviation 4.13
|
SECONDARY outcome
Timeframe: Month 1Thickness of the cornea measured in microns, measured as the change from baseline
Outcome measures
| Measure |
LessDrops
n=33 Eyes
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%
|
Standard of Care
n=33 Eyes
* 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
|
|---|---|---|
|
Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
|
3.18 microns
Standard Deviation 20.46
|
0.63 microns
Standard Deviation 18.37
|
SECONDARY outcome
Timeframe: Month 1Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline
Outcome measures
| Measure |
LessDrops
n=33 eyes
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%
|
Standard of Care
n=33 eyes
* 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
|
|---|---|---|
|
Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
|
-0.33 mmHg
Standard Deviation 3.35
|
-0.21 mmHg
Standard Deviation 3.37
|
Adverse Events
LessDrops
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LessDrops
n=33 participants at risk
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%
|
Standard of Care
n=33 participants at risk
* 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
|
|---|---|---|
|
Eye disorders
High intraocular pressure
|
3.0%
1/33 • One month
|
6.1%
2/33 • One month
|
|
Eye disorders
Rebound inflammation
|
3.0%
1/33 • One month
|
6.1%
2/33 • One month
|
|
Eye disorders
Macular edema
|
0.00%
0/33 • One month
|
3.0%
1/33 • One month
|
|
Eye disorders
Punctate epithelial erosions
|
0.00%
0/33 • One month
|
3.0%
1/33 • One month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place