Trial Outcomes & Findings for Loteprednol vs. Prednisolone and Fluorometholone (NCT NCT03123614)

NCT ID: NCT03123614

Last Updated: 2021-05-26

Results Overview

Intraocular pressure will be measured by applanation tonometry

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 131 participants
• Primary outcome timeframe: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op
• Results posted on: 2021-05-26

Participant Flow

Unit of analysis: Eyes

Participant milestones

Measure	Loteprednol Etabonate 0.5% Oph Gel Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp
Overall Study STARTED	57 114	74 147
Overall Study COMPLETED	57 114	74 147
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Loteprednol Etabonate 0.5% Oph Gel n=57 Participants Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp n=74 Participants Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp	Total n=131 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=57 Participants	0 Participants n=74 Participants	0 Participants n=131 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=57 Participants	74 Participants n=74 Participants	131 Participants n=131 Participants
Age, Categorical >=65 years	0 Participants n=57 Participants	0 Participants n=74 Participants	0 Participants n=131 Participants
Age, Continuous	34.6 years STANDARD_DEVIATION 8.8 • n=57 Participants	35.3 years STANDARD_DEVIATION 6.2 • n=74 Participants	35.0 years STANDARD_DEVIATION 7.3 • n=131 Participants
Sex: Female, Male Female	24 Participants n=57 Participants	36 Participants n=74 Participants	60 Participants n=131 Participants
Sex: Female, Male Male	33 Participants n=57 Participants	38 Participants n=74 Participants	71 Participants n=131 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	57 Participants n=57 Participants	74 Participants n=74 Participants	131 Participants n=131 Participants
Intraocular Pressure	14.38 mmHg STANDARD_DEVIATION 2.11 • n=57 Participants	14.30 mmHg STANDARD_DEVIATION 2.13 • n=74 Participants	14.34 mmHg STANDARD_DEVIATION 2.12 • n=131 Participants

PRIMARY outcome

Timeframe: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op

Intraocular pressure will be measured by applanation tonometry

Outcome measures

Measure	Loteprednol Etabonate 0.5% Oph Gel n=57 Participants Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp n=74 Participants Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp
Change in Intraocular Pressure (IOP) From Baseline Through Month 3 Baseline intraocular pressure (IOP)	14.38 mmHg Standard Deviation 2.11	14.30 mmHg Standard Deviation 2.13
Change in Intraocular Pressure (IOP) From Baseline Through Month 3 IOP 1 week postop	13.67 mmHg Standard Deviation 2.34	13.28 mmHg Standard Deviation 3.37
Change in Intraocular Pressure (IOP) From Baseline Through Month 3 IOP 1 month postop	14.15 mmHg Standard Deviation 2.88	14.60 mmHg Standard Deviation 4.20
Change in Intraocular Pressure (IOP) From Baseline Through Month 3 IOP 2 months postop	13.36 mmHg Standard Deviation 2.53	13.16 mmHg Standard Deviation 2.80
Change in Intraocular Pressure (IOP) From Baseline Through Month 3 IOP 3 months postop	13.15 mmHg Standard Deviation 2.43	12.22 mmHg Standard Deviation 2.38

SECONDARY outcome

Timeframe: 12 months

As determined by slit lamp examination

Outcome measures

Measure	Loteprednol Etabonate 0.5% Oph Gel n=114 Eyes Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp n=147 Eyes Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp
Number of Eyes With Corneal Haze	3 Eyes	7 Eyes

SECONDARY outcome

Timeframe: 3 months

Best uncorrected visual acuity will be measured at 3 months

Outcome measures

Measure	Loteprednol Etabonate 0.5% Oph Gel n=57 Participants Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp n=74 Participants Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp
Uncorrected Visual Acuity	-0.078 logMAR Standard Deviation 0.10	-0.075 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 3 months

Best uncorrected visual acuity will be measured at 3 months

Outcome measures

Measure	Loteprednol Etabonate 0.5% Oph Gel n=57 Participants Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp n=74 Participants Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp
Best Corrected Visual Acuity at 3 Months	-0.120 logMAR Standard Deviation 0.059	-0.114 logMAR Standard Deviation 0.03

Adverse Events

Loteprednol Etabonate 0.5% Oph Gel

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Prednisolone Acetate 1% Oph Susp

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Loteprednol Etabonate 0.5% Oph Gel n=57 participants at risk Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp n=74 participants at risk Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp
Eye disorders Non-visually significant corneal haze	5.3% 3/57 • Number of events 3 • 3 years and 10 months	9.5% 7/74 • Number of events 7 • 3 years and 10 months

Additional Information

Mark Mifflin, MD

University of Utah Moran Eye Center

Phone: 801-213-4152

Email: Mark.Mifflin@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place