Trial Outcomes & Findings for Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax (NCT NCT02322528)

Results Overview

Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

baseline, 30 minutes, week 1, week 2

Results posted on

2015-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Administration of 0.5% Lotemax An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Administration of Lotemax n=10 Participants An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
Age, Continuous	56.7 years STANDARD_DEVIATION 4.92 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 30 minutes, week 1, week 2

Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.

Outcome measures

Outcome measures
Measure	Administration of 0.5% Lotemax n=10 Participants An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
Ocular Surface Temperature of Both Eyes baseline	33.95 degrees celcius Standard Deviation 0.13
Ocular Surface Temperature of Both Eyes 30 minutes	34.3 degrees celcius Standard Deviation 0.13
Ocular Surface Temperature of Both Eyes week 1	33.93 degrees celcius Standard Deviation 0.12
Ocular Surface Temperature of Both Eyes week 2	33.95 degrees celcius Standard Deviation 0.13

PRIMARY outcome

Timeframe: baseline, 30 minutes, week 1, week 2

Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.

Outcome measures

Outcome measures
Measure	Administration of 0.5% Lotemax n=10 Participants An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
Visual Quality baseline	0.48 microns Standard Deviation 0.04
Visual Quality 30 minutes	0.54 microns Standard Deviation 0.04
Visual Quality week 1	0.49 microns Standard Deviation 0.08
Visual Quality week 2	0.48 microns Standard Deviation 0.04

Adverse Events

Administration of 0.5% Lotemax

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. James V. Aquavella

University of Rochester

Phone: 585-276-7439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place