Trial Outcomes & Findings for Effect of Olopatadine on Allergic Tear Mediators (NCT NCT00609128)

Results Overview

Outcome: The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay. Eosinophils in eosinophils / square cm measured.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

1 week for tear collection, tears stored at - 80 C until used

Results posted on

2018-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Olopatadine one drop olopatadine in one eye only, two times per day at an interval of 6 to 8 hours for 1 week. This allows the untreated eye to be the control.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Olopatadine on Allergic Tear Mediators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olopatadine Treatment (Only One Eye) n=21 Participants one drop olopatadine in one eye only, two times per day at an interval of 6 to 8 hours for 1 week. This allows the untreated eye to be the control.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Region of Enrollment United States	21 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 week for tear collection, tears stored at - 80 C until used

Outcome: The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay. Eosinophils in eosinophils / square cm measured.

Outcome measures

Outcome measures
Measure	Tears From Olopatadine Treated Eyes n=10 Participants Allergic subjects treated one eye with olopatadine and did not treat other eye (control). Tears collected from both eyes and incubated with conjunctival epithelial cells. We determined whether tears collected from olopatadine treated eyes of subjects result in more or less purified peripheral blood eosinophil adhesion to conjunctival epithelial cells compared to tears collected from untreated eyes from the same subjects.	Tears From Untreated Eyes n=10 Participants Allergic subjects treated one eye with olopatadine and did not treat other eye (control). Tears collected from both eyes and incubated with conjunctival epithelial cells. We determined whether tears collected from olopatadine treated eyes of subjects result in more or less purified peripheral blood eosinophil adhesion to conjunctival epithelial cells compared to tears collected from untreated eyes from the same subjects.
Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion	4517 eosinophils/square cm epithelial cells Standard Error 485	5004 eosinophils/square cm epithelial cells Standard Error 445

Adverse Events

Olopatadine

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

Jim Stahl, PhD

University of Wisconsin-Madison

Phone: 608-263-6177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place