Trial Outcomes & Findings for Digital Device Users Who Are Treated With Systane Hydration PF (NCT NCT04837807)

Last Updated: 2022-10-10

Results Overview

Impact of Dry Eye on Daily Life (IDEEL) Work questions will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

2 weeks

Results posted on

2022-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Unit Dose, Then Multi-dose The participants first received the unit dose version of Systane Hydrataion PF, there was a one day washout period, and then they received the multi-dose version of Systane Hydration PF.	Multi Dose, Then Unit Dose The participants first received the multi-dose version of Systane Hydrataion PF, there was a one day washout period, and then they received the unit-dose version of Systane Hydration PF.
First Sequence (Week 1) STARTED	15	15
First Sequence (Week 1) Received Sequence	15	15
First Sequence (Week 1) COMPLETED	15	14
First Sequence (Week 1) NOT COMPLETED	0	1
Washout 1 Day STARTED	15	14
Washout 1 Day COMPLETED	14	14
Washout 1 Day NOT COMPLETED	1	0
Second Sequence (Week 2) STARTED	14	14
Second Sequence (Week 2) COMPLETED	14	14
Second Sequence (Week 2) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Unit Dose, Then Multi-dose The participants first received the unit dose version of Systane Hydrataion PF, there was a one day washout period, and then they received the multi-dose version of Systane Hydration PF.	Multi Dose, Then Unit Dose The participants first received the multi-dose version of Systane Hydrataion PF, there was a one day washout period, and then they received the unit-dose version of Systane Hydration PF.
First Sequence (Week 1) Withdrawal by Subject	0	1

Baseline Characteristics

This project featured a total of 30 participants, each participant received both treatments, however one patient was lost to follow up, and thus was not part of the crossover total.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=30 Participants Subjects were randomized to either a multi dose group or a unit dose group, each group used either a multi dose or unit does in order to apply Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. After 1 week subjects were switched from their starting group to the other group to determine which dispensing method was preferred. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Age, Continuous	28.6 Years STANDARD_DEVIATION 12 • n=30 Participants
Sex: Female, Male Female	21 Participants n=30 Participants • This project featured a total of 30 participants, each participant received both treatments, however one patient was lost to follow up, and thus was not part of the crossover total.
Sex: Female, Male Male	9 Participants n=30 Participants • This project featured a total of 30 participants, each participant received both treatments, however one patient was lost to follow up, and thus was not part of the crossover total.
Region of Enrollment United States	30 participants n=30 Participants • The project features only 30 participants, all participants got both treatments however one subject dropped out prior to the crossover and thus was not counted in the crossover total.

PRIMARY outcome

Timeframe: 2 weeks

Population: While we had 30 total subjects enroll we lost one person due to lack of interest in the study. As such she was not switched over to the next group and thus no scores other than baseline were collected.

Outcome measures

Outcome measures
Measure	Unit Dose n=30 Participants Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.	Multi Dose n=30 Participants Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection	81.4 score on a scale Standard Deviation 12.7	81.4 score on a scale Standard Deviation 12.7

SECONDARY outcome

Timeframe: Between groups at 2 weeks

Population: One person discontinued after the baseline visit and thus did not crossover between groups.

Subjects will report whether they preferred the unit-dose dispensing method or the multi-dose dispensing method via a forced choice questionnaire (forced choice with patient being required to pick if they like the unit-dose dispensing method or the multi-dose better).

Outcome measures

Outcome measures
Measure	Unit Dose n=29 Participants Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.	Multi Dose n=29 Participants Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
Drop Dispensing Method Preference	16 Participants	13 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: One subject was lost after the baseline visit. Thus OSDI scores for the week 1 and 2 visit could not be calculated for that individual.

The Ocular Surface Disease Index (OSDI) will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best).

Outcome measures

Outcome measures
Measure	Unit Dose n=29 Participants Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.	Multi Dose n=30 Participants Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
Ocular Surface Disease Index (OSDI) Questionnaire	14.3 score on a scale Standard Deviation 8.6	14.3 score on a scale Standard Deviation 8.6

Adverse Events

Unit Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multi Dose

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

Dr. Andrew Pucker

The University of Alabama at Birmingham

Phone: 920-579-2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place