Trial Outcomes & Findings for Clinical Evaluation of Systane® Balance in Dry Eye Subjects (NCT NCT02511379)

Results Overview

The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Baseline (Day 0), Day 45, Day 90

Results posted on

2018-10-31

Participant Flow

Participants were enrolled from 4 study sites located in India.

Participant milestones

Participant milestones
Measure	Systane Balance Propylene Glycol 0.6% eye drops, 1 drop QID (4 times/day) (with the last dose of each day at bedtime) in each eye for 90 days
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Systane Balance n=14 Participants Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 45, Day 90

Population: Analysis includes all participants with data present. Analysis was based on the eye with the higher corneal staining total score at screening or the right eye when both eyes have same corneal staining total score at screening, as observed.

The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).

Outcome measures

Outcome measures
Measure	Systane Balance n=14 Participants Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
Change From Baseline in Corneal Staining Total Score Change from baseline at Day 45	-3.1 units on a scale Interval -8.0 to 1.0
Change From Baseline in Corneal Staining Total Score Change from baseline at Day 90	-4.8 units on a scale Interval -11.0 to -1.0

Adverse Events

Systane Balance

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

Study Director Med Affairs

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place