Trial Outcomes & Findings for Tear Lipid Layer Thickness With Emollient Eye Drops (NCT NCT03380624)

Results Overview

Change in tear lipid layer thickness

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

15 minutes

Results posted on

2021-02-03

2 participants were found to be ineligible after completing the baseline visit.

Participant milestones
Measure	Refresh Optive Then Refresh Optive MEGA 3 The subjects are randomly assigned to one drop of Refresh Optive or Refresh Optive MEGA followed by measurement of lipid layer thickness at 15 minutes and 1 hour After which there is a washout period before Visit 2 - in which the measurements were repeated with the other eye drop.	Refresh Optive MEGA 3 Then Refresh Optive The subjects are randomly assigned to one drop of Refresh Optive or Refresh Optive MEGA followed by measurement of lipid layer thickness at 15 minutes and 1 hour After which there is a washout period before Visit 2 - in which the measurements were repeated with the other eye drop.
Overall Study STARTED	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Refresh Optive and Refresh Optive MEGA n=19 Participants The subjects are randomly assigned to Refresh Optive or Refresh Optive MEGA (Omega 3) with measurements of lipid layer thickness following at 15 minutes and 1 hour. After which there is a washout period before proceeding to the second eye drop at visit 2. Refresh Optive: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose Refresh Optimum OMEGA 3: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose \*All subjects completed both arms in this crossover study
Age, Customized Age 30 to 65	19 Participants n=19 Participants
Sex: Female, Male Female	13 Participants n=19 Participants
Sex: Female, Male Male	6 Participants n=19 Participants
Lipid layer thickness	40.9 nm STANDARD_DEVIATION 10.1 • n=19 Participants

Timeframe: 15 minutes

Change in tear lipid layer thickness

Outcome measures
Measure	Refresh Optive n=19 Participants Participants were first randomized to have 1 drop of Refresh Optive instilled in each eye with measurements of lipid layer thickness following at 15 minutes and 1 hour. After which there is a washout period before proceeding to a second visit in which Refresh Optive MEGA-3 was utilized and the measurements were repeated. Refresh Optive: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose Refresh Optimum OMEGA 3: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose \*All subjects completed both arms in this crossover study	Refresh Optive MEGA-3 n=19 Participants Participants were first randomized to have 1 drop of Refresh Optive MEGA-3 instilled in each eye with measurements of lipid layer thickness following at 15 minutes and 1 hour. After which there is a washout period before proceeding to a second visit in which Refresh Optive was utilized and the measurements were repeated.
Change in Tear Lipid Layer Thickness	4.8 nm Standard Deviation 14.9	8.8 nm Standard Deviation 11.5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

The Ohio State University College of Optometry

Phone: 614-292-2020