Trial Outcomes & Findings for Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children. (NCT NCT01475643)

Last Updated: 2019-06-11

Results Overview

Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D \[g20 Diopter\] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal 1. = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal 2. = Moderate Moderate anterior chamber clouding 3. = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished 4. = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

107 participants

Primary outcome timeframe

Postoperative Day 29

Results posted on

2019-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Loteprednol Etabonate Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.	Prednisolones Acetate Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Overall Study STARTED	54	53
Overall Study COMPLETED	40	43
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Loteprednol Etabonate n=53 Participants Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.	Prednisolones Acetate n=52 Participants Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.	Total n=105 Participants Total of all reporting groups
Age, Continuous	3.7 years STANDARD_DEVIATION 3.22 • n=5 Participants	4.3 years STANDARD_DEVIATION 3.39 • n=7 Participants	4 years STANDARD_DEVIATION 3.305 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	32 Participants n=7 Participants	61 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants	52 participants n=7 Participants	105 participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative Day 29

Population: Proportion of subjects with anterior chamber inflammation

Outcome measures

Outcome measures
Measure	Loteprednol Etabonate n=53 Participants Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.	Prednisolones Acetate n=48 Participants Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Anterior Chamber Inflammation	.913 grade of anterior chamber cells Interval 0.668 to 1.158	.783 grade of anterior chamber cells Interval 0.528 to 1.038

SECONDARY outcome

Timeframe: Over all visits 42 days

Population: Proportion of subjects with anterior chamber flare.

Anterior Chamber Flare (for those subjects that could be examined with a slit lamp): Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect 1. = Mild Tyndall effect barely discernible 2. = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly 3. = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly 4. = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance

Outcome measures

Outcome measures
Measure	Loteprednol Etabonate n=36 Participants Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.	Prednisolones Acetate n=42 Participants Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Anterior Chamber Cells & Flare	.192 Grade of anterior chamber flare Interval 0.034 to 0.35	.341 Grade of anterior chamber flare Interval 0.157 to 0.507

Adverse Events

Loteprednol Etabonate

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Prednisolones Acetate

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Loteprednol Etabonate n=54 participants at risk Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.	Prednisolones Acetate n=53 participants at risk Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Eye disorders Vitreous Disorder	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Glaucoma	3.7% 2/54 • Number of events 2 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Bronchiolitis	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).

Other adverse events

Additional Information

Denise Raimondo

Valeant Pharmaceuticals NA

Phone: 9089721885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Loteprednol Etabonate n=54 participants at risk Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.	Prednisolones Acetate n=53 participants at risk Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Eye disorders Amblyopia	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders cataract	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Conjunctivitis	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Eye Pain	11.1% 6/54 • Number of events 6 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	7.5% 4/53 • Number of events 4 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Eyelid Odema	7.4% 4/54 • Number of events 4 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	7.5% 4/53 • Number of events 4 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Glaucoma	3.7% 2/54 • Number of events 4 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Ocular hyperemia	5.6% 3/54 • Number of events 3 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Iridocyclitis	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders lacrimation increased	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Strabismus	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders Vitreous Disorder	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders photophobia	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Injury, poisoning and procedural complications Suture Related Complication	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
General disorders Discomfort	3.7% 2/54 • Number of events 2 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	5.7% 3/53 • Number of events 3 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
General disorders Installation Site Pain	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Injury, poisoning and procedural complications injury	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	3.8% 2/53 • Number of events 2 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Injury, poisoning and procedural complications Post Procedural Complication	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Injury, poisoning and procedural complications Post Capsule Opacification	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Eye disorders iritis	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Gastrointestinal disorders Diarrhoea	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
General disorders Feeling Hot	0.00% 0/54 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
General disorders Pyrexia	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	3.8% 2/53 • Number of events 2 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Infections and infestations Ear Infection	3.7% 2/54 • Number of events 2 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Infections and infestations Nasopharyngitis	3.7% 2/54 • Number of events 3 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	7.5% 4/53 • Number of events 4 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Infections and infestations Gastroenteritis Viral	3.7% 2/54 • Number of events 2 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Infections and infestations Pharyngitis Strepococcal	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Injury, poisoning and procedural complications Arthropod Bite	1.9% 1/54 • Number of events 1 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	0.00% 0/53 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
Respiratory, thoracic and mediastinal disorders Cough	3.7% 2/54 • Number of events 2 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).	1.9% 1/53 • Number of events 2 • 29 days The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).