Trial Outcomes & Findings for LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (NCT NCT02786901)

NCT ID: NCT02786901

Last Updated: 2021-01-08

Results Overview

Slit lamp examination was performed. 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. Complete resolution of AC cells was defined as Cell score = 0 in the study eye.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 600 participants
• Primary outcome timeframe: 8 days
• Results posted on: 2021-01-08

Participant Flow

Participant milestones

Measure	Vehicle BID and TID Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID Loteprednol Etabonate Ophthalmic Gel dosed TID
Overall Study STARTED	199	201	200
Overall Study COMPLETED	122	145	159
Overall Study NOT COMPLETED	77	56	41

Reasons for withdrawal

Measure	Vehicle BID and TID Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID Loteprednol Etabonate Ophthalmic Gel dosed TID
Overall Study Adverse Event	1	1	2
Overall Study Physician Decision	1	0	0
Overall Study Rescue Therapy Use	71	49	33
Overall Study Subject Request/Lost to Follow up	1	5	5
Overall Study Disallowed medication	1	1	0
Overall Study Randomized in error	2	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Vehicle BID and TID n=199 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=200 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID	Total n=600 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 8.92 • n=93 Participants	68.3 years STANDARD_DEVIATION 9.11 • n=4 Participants	67.9 years STANDARD_DEVIATION 9.32 • n=27 Participants	68.2 years STANDARD_DEVIATION 9.11 • n=483 Participants
Sex: Female, Male Female	116 Participants n=93 Participants	117 Participants n=4 Participants	130 Participants n=27 Participants	363 Participants n=483 Participants
Sex: Female, Male Male	83 Participants n=93 Participants	84 Participants n=4 Participants	70 Participants n=27 Participants	237 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Asian	7 Participants n=93 Participants	13 Participants n=4 Participants	9 Participants n=27 Participants	29 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Black or African American	14 Participants n=93 Participants	23 Participants n=4 Participants	23 Participants n=27 Participants	60 Participants n=483 Participants
Race (NIH/OMB) White	169 Participants n=93 Participants	158 Participants n=4 Participants	163 Participants n=27 Participants	490 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=93 Participants	4 Participants n=4 Participants	3 Participants n=27 Participants	16 Participants n=483 Participants
Iris Color Blue	50 Participants n=93 Participants	47 Participants n=4 Participants	49 Participants n=27 Participants	146 Participants n=483 Participants
Iris Color Brown	111 Participants n=93 Participants	115 Participants n=4 Participants	112 Participants n=27 Participants	338 Participants n=483 Participants
Iris Color Green	17 Participants n=93 Participants	9 Participants n=4 Participants	5 Participants n=27 Participants	31 Participants n=483 Participants
Iris Color Hazel	20 Participants n=93 Participants	28 Participants n=4 Participants	32 Participants n=27 Participants	80 Participants n=483 Participants
Iris Color Other	1 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants

PRIMARY outcome

Timeframe: 8 days

Population: Missing values and post rescue values imputed as failures.

Slit lamp examination was performed. 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. Complete resolution of AC cells was defined as Cell score = 0 in the study eye.

Outcome measures

Measure	Vehicle BID and TID n=199 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=200 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID
Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8)	40 Participants	52 Participants	61 Participants

PRIMARY outcome

Timeframe: 8 days

Population: Missing values and post rescue values imputed as failures.

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 a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0.

Outcome measures

Measure	Vehicle BID and TID n=199 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=200 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID
Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8)	99 Participants	151 Participants	151 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Missing values and post rescue values imputed as failures.

Slit lamp examination was performed. 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. Complete resolution of AC cells was defined as Cell score = 0 in the study eye.

Outcome measures

Measure	Vehicle BID and TID n=190 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=198 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID
Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit.	67 Participants	82 Participants	94 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Missing values and post rescue values imputed as failures.

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 a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0.

Outcome measures

Measure	Vehicle BID and TID n=190 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=198 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID
Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit	122 Participants	168 Participants	170 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Missing values and post rescue values imputed as failures.

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 a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution.

Outcome measures

Measure	Vehicle BID and TID n=190 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=198 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID
Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit	107 Participants	143 Participants	153 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Missing values and post rescue values imputed as failures.

Slit lamp examination was performed. 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. 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 a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution.

Outcome measures

Measure	Vehicle BID and TID n=190 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=198 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID
Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit	66 Participants	82 Participants	92 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Missing values and post-rescue values imputed using last observation carried forward.

Slit lamp examination was performed. 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. 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 a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). The combined endpoint was defined as the sum of the scores for AC cells and AC flare. Summed Anterior Chamber (AC) Cell and Flare Scores could range from 0 to 8.

Outcome measures

Measure	Vehicle BID and TID n=190 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=198 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID
Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit	-1.2 score on a scale Standard Deviation 1.90	-2.0 score on a scale Standard Deviation 1.50	-2.1 score on a scale Standard Deviation 1.50

SECONDARY outcome

Timeframe: 8 days

A participant was considered a treatment failure at Visit 5 if they started any rescue medication prior to, or on the day of, Visit 5. If a subject did not have a Visit 5, due either to early discontinuation or to a missed visit, then treatment failure at Visit 5 was defined as starting rescue medication prior to, or on, Postoperative Day 8.

Outcome measures

Measure	Vehicle BID and TID n=199 Participants Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=201 Participants Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=200 Participants Loteprednol Etabonate Ophthalmic Gel dosed TID
Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8)	62 Participants	23 Participants	20 Participants

Adverse Events

Vehicle BID and TID

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

LE Gel BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LE Gel TID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vehicle BID and TID n=198 participants at risk Vehicle Gel dosed BID and Vehicle Gel dosed TID, combined	LE Gel BID n=202 participants at risk Loteprednol Etabonate Ophthalmic Gel dosed BID	LE Gel TID n=199 participants at risk Loteprednol Etabonate Ophthalmic Gel dosed TID
Metabolism and nutrition disorders Hypokalemia	0.51% 1/198 • Number of events 1 • 14 days The Safety population was used for reporting of adverse events. One participant was included in the vehicle group in the ITT (Intent to Treat) population but did not administer study drug, so this participant was excluded from the Safety population. Another participant, randomized to the LE gel TID group, and included in this treatment group in the ITT population, actually received LE gel BID and so was included in LE gel BID treatment group in the Safety population	0.00% 0/202 • 14 days The Safety population was used for reporting of adverse events. One participant was included in the vehicle group in the ITT (Intent to Treat) population but did not administer study drug, so this participant was excluded from the Safety population. Another participant, randomized to the LE gel TID group, and included in this treatment group in the ITT population, actually received LE gel BID and so was included in LE gel BID treatment group in the Safety population	0.00% 0/199 • 14 days The Safety population was used for reporting of adverse events. One participant was included in the vehicle group in the ITT (Intent to Treat) population but did not administer study drug, so this participant was excluded from the Safety population. Another participant, randomized to the LE gel TID group, and included in this treatment group in the ITT population, actually received LE gel BID and so was included in LE gel BID treatment group in the Safety population

Other adverse events

Adverse event data not reported

Additional Information

Study Manager

Bausch Health

Phone: (908) 242-8287

Email: sandra.narain@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
• Publication restrictions are in place

Restriction type: OTHER