Trial Outcomes & Findings for Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops (NCT NCT00610480)

NCT ID: NCT00610480

Last Updated: 2020-11-19

Results Overview

To evaluate the effect of OTC artificial tears on tear film stability, the evaporation rate (µl/cm2/min) will be determined with an Evaporometer for the left eye only of each patient. For each arm, the evaporation rates will be determined at baseline and at 30 minutes after installation of artificial tears. Evaporation rates in all cases will be determined under two different relative humidity (RH) conditions, RH from 25-35% and RH from 35-45%.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline and 30 minutes after artificial tear instillation
• Results posted on: 2020-11-19

Participant Flow

Subjects with dry eye disease will be recruited from Ophthalmology clinic patients and otherwise healthy volunteers who are students or employees of the University of Texas Southwestern Medical Center.

Participant milestones

Measure	Optive, Then Systane Artificial Tears Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Systane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.	Systane, Then Optane Artificial Tears Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops

Baseline characteristics by cohort

Measure	Optive, Then Systane n=10 Participants Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Systane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.	Systane, Then Optive n=10 Participants Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 30 minutes after artificial tear instillation

Population: Total participant enrollment is 20 (3 men and 17 women). Ten participants were assigned to each sequence, so a total of 20 participants experienced each intervention.

To evaluate the effect of OTC artificial tears on tear film stability, the evaporation rate (µl/cm2/min) will be determined with an Evaporometer for the left eye only of each patient. For each arm, the evaporation rates will be determined at baseline and at 30 minutes after installation of artificial tears. Evaporation rates in all cases will be determined under two different relative humidity (RH) conditions, RH from 25-35% and RH from 35-45%.

Outcome measures

Measure	Optive Artificial Tears n=20 Participants Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Systane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.	Systane Artificial Tears n=20 Participants Artificial Tear Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, a baseline evaporation rate will be measured, artificial tears (Optane, 40 microliters) will be administered, and evaporation rate measurements will be repeated 30 minutes later.
Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears Baseline:25-35%	0.047 (µl/cm2/min) Standard Deviation 0.019	0.049 (µl/cm2/min) Standard Deviation 0.023
Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears Baseline:35-45%	0.031 (µl/cm2/min) Standard Deviation 0.014	0.032 (µl/cm2/min) Standard Deviation 0.016
Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears 30 minutes:25-35%	0.052 (µl/cm2/min) Standard Deviation 0.024	0.051 (µl/cm2/min) Standard Deviation 0.025
Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears 30 minutes:35-45%	0.034 (µl/cm2/min) Standard Deviation 0.016	0.032 (µl/cm2/min) Standard Deviation 0.014

Adverse Events

Optive Artificial Tears

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Systane Artificial Tears

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

Peter Chen

UT Southwestern Medical Center

Phone: 214-648-3837

Email: peter.chen@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place