Trial Outcomes & Findings for Evaluation of Ocular Comfort With ISTA Tears vs Systane (NCT NCT01650584)

Results Overview

There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

30 days

Results posted on

2024-10-08

Participant Flow

There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	All Participants Each participant has 2 eyes. There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total).
Overall Study STARTED	35 70
Overall Study ISTA Tears	35 35
Overall Study Systane	35 35
Overall Study COMPLETED	35 70
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Ocular Comfort With ISTA Tears vs Systane

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants Received Both ISTA Tears and Systane n=70 Eyes ISTA Tears: sterile ophthalmic solution used in the right eye. Systane: Sterile ophthalmic solution used in the left eye.
Age, Customized At least 18 years of age	35 Participants n=5 Participants
Sex/Gender, Customized Both male or female	35 Participants n=5 Participants
Region of Enrollment United States	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total).

There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither.

Outcome measures

Outcome measures
Measure	Overall Participants n=35 Participants
Percentage of Participants With Preference for One of the Treatments Neither preferred	1 Participants
Percentage of Participants With Preference for One of the Treatments ISTA Tears preferred	23 Participants
Percentage of Participants With Preference for One of the Treatments Systane preferred	11 Participants

Adverse Events

Participants Received Both ISTA Tears and Systane

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

Bausch Health

Phone: 908-300-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for detail.
Publication restrictions are in place

Restriction type: OTHER