Trial Outcomes & Findings for The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects (NCT NCT01718028)

Results Overview

NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

Baseline (Day 0), Day 30

Results posted on

2014-01-06

Participant Flow

Participants were recruited from 1 study center located in Argentina.

Of the 51 enrolled, 2 participants withdrew their consent prior to receiving treatment and were exited from the study. This reporting group includes all participants who received treatment.

Participant milestones

Participant milestones
Measure	SYSTANE® BALANCE Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days	LARMABAK® Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
Overall Study STARTED	25	24
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SYSTANE® BALANCE n=25 Participants Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days	LARMABAK® n=24 Participants Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days	Total n=49 Participants Total of all reporting groups
Age Continuous	45.52 years STANDARD_DEVIATION 20.06 • n=5 Participants	42.96 years STANDARD_DEVIATION 17.71 • n=7 Participants	44.27 years STANDARD_DEVIATION 18.79 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Argentina	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 30

Population: Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit

NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.

Outcome measures

Outcome measures
Measure	SYSTANE® BALANCE n=25 Participants Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days	LARMABAK® n=24 Participants Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
Mean Change From Baseline in NITFBUT at Day 30	2.83 seconds Standard Deviation 0.74	0.66 seconds Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 14

Population: Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit

NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.

Outcome measures

Outcome measures
Measure	SYSTANE® BALANCE n=25 Participants Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days	LARMABAK® n=24 Participants Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
Mean Change From Baseline in NITFBUT at Day 14	1.98 seconds Standard Deviation 0.60	0.65 seconds Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 14, Day 30

Population: Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit

NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.

Outcome measures

Outcome measures
Measure	SYSTANE® BALANCE n=25 Participants Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days	LARMABAK® n=24 Participants Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
Mean NITFBUT by Visit Baseline	4.60 seconds Standard Deviation 0.69	4.93 seconds Standard Deviation 0.80
Mean NITFBUT by Visit Day 14	6.58 seconds Standard Deviation 0.74	5.57 seconds Standard Deviation 0.93
Mean NITFBUT by Visit Day 30	7.43 seconds Standard Deviation 0.51	5.59 seconds Standard Deviation 0.66

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 14, Day 30

Population: Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit

NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.

Outcome measures

Outcome measures
Measure	SYSTANE® BALANCE n=25 Participants Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days	LARMABAK® n=24 Participants Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
Percent Change From Baseline in NITFBUT by Visit Percent Change from Baseline at Day 14	44.99 percent change Standard Deviation 19.46	14.35 percent change Standard Deviation 17.88
Percent Change From Baseline in NITFBUT by Visit Percent Change from Baseline at Day 30	65.03 percent change Standard Deviation 28.41	15.06 percent change Standard Deviation 14.48

Adverse Events

SYSTANE® BALANCE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LARMABAK®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Abayomi Ogundele, Pharm.D.

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER