Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01996839

Enrollment

514

Registered

2013-11-27

Start date

2013-12-31

Completion date

2014-07-31

Last updated

2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Inflammation, Pain

Brief summary

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

Detailed description

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative inflammation and pain following cataract surgery.

Interventions

DRUGLoteprednol Etabonate Gel (BID)

One drop of LE gel instilled into the study eye two times per day (BID) for 14 days

DRUGLoteprednol Etabonate Gel (TID)

One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.

DRUGVehicle (BID)

One drop of vehicle instilled into the study eye two times per day (BID) for 14 days

DRUGVehicle (TID)

One drop of vehicle instilled into the study eye three times per day (TID) for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Visit 1 (Screening Visit) * Be willing and able to comply with all treatment and follow-up/study procedures. * Be a candidate for routine, uncomplicated cataract surgery Visit 3 (Postoperative Day 1) * Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye. * Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion criteria

* Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study. * Have known hypersensitivity or contraindication to the study drug(s) or their components.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells	8 days	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Percentage of Participants With Grade 0 Pain in the Study Eye.	8 days	Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.

Secondary

Measure	Time frame	Description
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit	18 days	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.	18 days	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.	18 days	Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.	18 days	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).

Countries

United States

Participant flow

Recruitment details

The 2 vehicle arms were combined into 1 treatment group in the statistical analysis, and hence the study has 3 treatment groups (ie, Loteprednol Etabonate Gel TID, Loteprednol Etabonate Gel BID, and \[combined\] vehicle groups).

Participants by arm

Arm	Count
Vehicle (BID and TID) Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID) and three times daily (TID), combined arms One drop of vehicle instilled into the study eye two times per day (BID) and three times a day (TID) for 14 days	172
Loteprednol Etabonate Gel (BID) Loteprednol Etabonate Gel 0.38% administered two times daily (BID). Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days	171
Loteprednol Etabonate Gel (TID) Loteprednol Gel 0.38% administered three times daily (TID). Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.	171
Total	514

Baseline characteristics

Characteristic	Vehicle (BID and TID)	Loteprednol Etabonate Gel (BID)	Loteprednol Etabonate Gel (TID)	Total
Age, Continuous	69.0 years STANDARD_DEVIATION 8.56	70.0 years STANDARD_DEVIATION 8.34	70.5 years STANDARD_DEVIATION 8.15	69.8 years STANDARD_DEVIATION 8.36
Sex: Female, Male Female	100 Participants	94 Participants	89 Participants	283 Participants
Sex: Female, Male Male	72 Participants	77 Participants	82 Participants	231 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 172	0 / 171	0 / 170
other Total, other adverse events	0 / 172	0 / 171	0 / 170
serious Total, serious adverse events	1 / 172	1 / 171	0 / 170