Trial Outcomes & Findings for Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery (NCT NCT01344226)

Results Overview

Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.

Recruitment status

COMPLETED

Target enrollment

49 participants

Primary outcome timeframe

baseline to 6 weeks

Results posted on

2018-10-22

Participant Flow

Patients in one location of one surgeon's clinic about to undergo cataract surgery were recruited from July 2011 to May 2013.

patients had to be off of steroids for 14 days with no depot steroid injection for 30 days

Participant milestones

Participant milestones
Measure	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati Subjects instilled one drop of topical loteprednol 0.5% suspension qid into the operative eye four times daily for a maximum of 22 days. Dosing began on the day of surgery and continued for 21 days postoperatively.
Overall Study STARTED	49
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati Subjects instilled one drop of topical loteprednol 0.5% suspension qid into the operative eye four times daily for a maximum of 22 days. Dosing began on the day of surgery and continued for 21 days postoperatively.
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	3
Overall Study Lack of Efficacy	3

Baseline Characteristics

Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati n=49 Participants patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants
Age, Continuous	68.93 years STANDARD_DEVIATION 9.61 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 6 weeks

Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.

Outcome measures

Outcome measures
Measure	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati n=49 Participants patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.	-1.8 mm Hg Standard Error 1.06

SECONDARY outcome

Timeframe: change in ETDRS letters read baseline to 6 weeks

Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.

Outcome measures

Outcome measures
Measure	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati n=41 Participants patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
ETDRS Letters Read Over Early Postoperative Period	8.05 change in ETDRS letters read Standard Error 2.14

SECONDARY outcome

Timeframe: baseline to 6 weeks

Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (\>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome.

Outcome measures

Outcome measures
Measure	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati n=41 Participants patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification	0.25 units on a scale Standard Error 1.11

SECONDARY outcome

Timeframe: baseline to 6 weeks

Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control.

Outcome measures

Outcome measures
Measure	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati n=41 Participants patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Flare Scores in Early Postoperative Period	0.08 units on a scale Standard Error 0.78

Adverse Events

Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati n=49 participants at risk patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Eye disorders increasing ocular cell	6.1% 3/49 • Number of events 3 • 6 weeks after phacoemulsification was performed

Additional Information

Melissa Morrison Toyos

Discover Vision Centers

Phone: 8164781230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place