Trial Outcomes & Findings for Efficacy and Safety Study of FID 119515A (NCT NCT01833117)

Results Overview

Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

Baseline, 60 minutes

Results posted on

2018-06-29

Participant Flow

Participants were recruited from 3 study centers located in the US.

Of the 75 enrolled, 13 participants failed to meet inclusion/exclusion criteria and were exited as screen failures prior to randomization. This reporting group includes all enrolled and randomized participants (62).

Participant milestones

Participant milestones
Measure	FID 119515A FID 119515A, 1 drop instilled in the study eye, single dose	Blink Blink® Tears, 1 drop instilled in the study eye, single dose
Overall Study STARTED	43	19
Overall Study COMPLETED	43	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Study of FID 119515A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FID 119515A n=43 Participants FID 119515A, 1 drop instilled in the study eye, single dose	Blink n=19 Participants Blink® Tears, 1 drop instilled in the study eye, single dose	Total n=62 Participants Total of all reporting groups
Age, Continuous	54.6 years STANDARD_DEVIATION 14.86 • n=5 Participants	60.4 years STANDARD_DEVIATION 14.48 • n=7 Participants	56.4 years STANDARD_DEVIATION 14.87 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	18 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 60 minutes

Population: This analysis population includes all randomized participants.

Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.

Outcome measures

Outcome measures
Measure	FID 119515A n=43 Participants FID 119515A, 1 drop instilled in the study eye, single dose	Blink n=19 Participants Blink® Tears, 1 drop instilled in the study eye, single dose
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes	1.2 seconds Standard Error 0.23	1.2 seconds Standard Error 0.22

SECONDARY outcome

Timeframe: 0 to 60 minutes

Population: This analysis population includes all randomized participants.

Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.

Outcome measures

Outcome measures
Measure	FID 119515A n=43 Participants FID 119515A, 1 drop instilled in the study eye, single dose	Blink n=19 Participants Blink® Tears, 1 drop instilled in the study eye, single dose
Area Under Curve (AUC) of TBUT From 0 to 60 Minutes	4.5 seconds x hours Standard Deviation 0.22	4.5 seconds x hours Standard Deviation 0.21

Adverse Events

FID 119515A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blink

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

Michela Montecchi-Palmer, Clinical Project Lead

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