Trial Outcomes & Findings for Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis (NCT NCT01028027)

Results Overview

The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

357 participants

Primary outcome timeframe

Baseline, Day 15

Results posted on

2012-02-28

Participant Flow

This study was conducted at seven sites, by seven Investigators in the People's Republic of China. First participant was enrolled 10/21/2009 and last participant visit was 2/9/2010.

A total of 357 participants with clinically diagnosed blepharokeratoconjunctivitis (BKC) in at least one eye were enrolled. 328 participants completed the study.

Participant milestones

Participant milestones
Measure	Loteprednol and Tobramycin Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Overall Study STARTED	180	177
Overall Study COMPLETED	164	164
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Loteprednol and Tobramycin Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Overall Study Lost to Follow-up	4	1
Overall Study Withdrawal by Subject	5	3
Overall Study Adverse Event	4	7
Overall Study Protocol Violation	3	1
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Loteprednol and Tobramycin n=180 Participants Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone n=177 Participants Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Total n=357 Participants Total of all reporting groups
Age Continuous	40.8 Years STANDARD_DEVIATION 13.63 • n=5 Participants	41.72 Years STANDARD_DEVIATION 13.54 • n=7 Participants	41.26 Years STANDARD_DEVIATION 13.57 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	113 Participants n=7 Participants	236 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	64 Participants n=7 Participants	121 Participants n=5 Participants
Region of Enrollment Singapore	180 participants n=5 Participants	177 participants n=7 Participants	357 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 15

Population: The PP population was the population used for the primary efficacy analysis.

The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).

Outcome measures

Outcome measures
Measure	Loteprednol and Tobramycin n=156 Participants Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone n=152 Participants Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population	-11.63 Scores on a scale Standard Deviation 4.56	-12.41 Scores on a scale Standard Deviation 4.71

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: The ITT population was used in this secondary efficacy parameter.

The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

Outcome measures

Outcome measures
Measure	Loteprednol and Tobramycin n=164 Participants Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone n=165 Participants Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population	-11.64 Score on a scale Standard Deviation 4.55	-11.98 Score on a scale Standard Deviation 4.95

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: The PP population was used for this secondary efficacy parameters.

The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.

Outcome measures

Outcome measures
Measure	Loteprednol and Tobramycin n=155 Participants Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone n=150 Participants Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population	-9.20 Score on a scale Standard Deviation 3.94	-10.21 Score on a scale Standard Deviation 4.23

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: The ITT population was used in this secondary efficacy parameter.

The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

Outcome measures

Outcome measures
Measure	Loteprednol and Tobramycin n=172 Participants Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone n=171 Participants Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population	-8.91 Score on a scale Standard Deviation 4.24	-9.96 Score on a scale Standard Deviation 4.27

SECONDARY outcome

Timeframe: Baseline, Day 3

Population: The PP population was used for this secondary efficacy parameters.

The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.

Outcome measures

Outcome measures
Measure	Loteprednol and Tobramycin n=155 Participants Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone n=152 Participants Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population	-5.66 Score on a scale Standard Deviation 3.46	-5.98 Score on a scale Standard Deviation 3.68

SECONDARY outcome

Timeframe: Baseline, Day 3

Population: The ITT population was used for this secondary efficacy parameters.

The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.

Outcome measures

Outcome measures
Measure	Loteprednol and Tobramycin n=177 Participants Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone n=176 Participants Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population	-5.54 Score on a scale Standard Deviation 3.48	-5.92 Score on a scale Standard Deviation 3.69

Adverse Events

Loteprednol and Tobramycin

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Tobramycin and Dexamethasone

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Loteprednol and Tobramycin n=177 participants at risk Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.	Tobramycin and Dexamethasone n=177 participants at risk Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Eye disorders Increased IOP	9.0% 16/177 • Number of events 52 • 14 days	20.3% 36/177 • Number of events 52 • 14 days

Additional Information

Tuyen Ong, MD

Bausch & Lomb Incorporated

Phone: (973) 360-6389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Publication restrictions are in place

Restriction type: OTHER