Trial Outcomes & Findings for The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability (NCT NCT01013077)

Last Updated: 2025-06-12

Results Overview

Change in contrast sensitivity with administration of the artificial tear. During a visit, contrast sensitivity is initially monitored for several minutes (i.e., pre-artificial tear application contrast sensitivity) and the artificial tear is then applied and the contrast sensitivity is continually measured for several more minutes (post-artificial tear application contrast sensitivity). The administration of the artificial tear decreases contrast sensitivity for approximately a minute. The data reported in the table is the change in contrast sensitivity from pre-artificial tear administration to the peak loss in contrast sensitivity after the artificial tear administration (negative values). This procedure is carried out before the subjects use artificial tears on a daily basis (i.e., baseline data) and for several weeks after using artificial tears on a daily basis (i.e., weeks 1, 2, and 4) to determine if there is an adaptation to the artificial tear.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline, 1 week, 2 weeks, 4 weeks

Results posted on

2025-06-12

Participant Flow

Subjects were recruited from the patients and staff of the clinic. The recruitment period was from 10/1/2009 till 7/30/2010.

The subjects were not allowed to use artificial tears for 1 week before the study started.

Participant milestones

Participant milestones
Measure	Optive, Soothe, New Emulsion Optive was the first drop used followed by Soothe and then the New Emulsion.	Soothe, New Emulsion, Optive Soothe was the first drop used followed by the New Emulsion and then Optive.	New Emulsion, Optive, Soothe The New Emulsion was the first drop used followed by Optive and then Soothe..
Overall Study STARTED	7	7	6
Overall Study COMPLETED	7	7	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optive, Soothe, New Emulsion n=7 Participants Drop order was Optive, then Soothe, then New Emulsion.	Soothe, New Emulsion, Optive n=7 Participants Drop order was Soothe, then New Emulsion, then Optive.	New Emulsion, Optive, Soothe n=6 Participants Drop order was New Emulsion, then Optive, then Soothe.	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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	23.8 years STANDARD_DEVIATION 1.60 • n=5 Participants	22.6 years STANDARD_DEVIATION 1.67 • n=7 Participants	24.4 years STANDARD_DEVIATION 2.07 • n=5 Participants	23.6 years STANDARD_DEVIATION 1.82 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	20 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 1 week, 2 weeks, 4 weeks

Outcome measures

Outcome measures
Measure	Optive Normal n=10 Participants Commercial drop. Normal subjects.	Soothe Normal n=10 Participants Commercial drop. Normal subjects.	New Emulsion Normal n=10 Participants New formulation. Normal subjects.	Optive Dry Eye n=10 Participants Commercial drop. Dry eye subjects.	Soothe Dry Eye n=10 Participants Commercial drop. Dry eye subjects.	New Emulsion Dry Eye n=10 Participants New formulation. Dry eye subjects.
Contrast Sensitivity Baseline	-0.375 arbitrary units Standard Error 0.139	-0.169 arbitrary units Standard Error 0.133	-0.313 arbitrary units Standard Error 0.094	-0.264 arbitrary units Standard Error 0.117	-0.268 arbitrary units Standard Error 0.081	-0.364 arbitrary units Standard Error 0.063
Contrast Sensitivity Week 1	-0.373 arbitrary units Standard Error 0.111	-0.118 arbitrary units Standard Error 0.148	-0.290 arbitrary units Standard Error 0.081	-0.275 arbitrary units Standard Error 0.083	-0.289 arbitrary units Standard Error 0.113	-0.446 arbitrary units Standard Error 0.090
Contrast Sensitivity Week 2	-0.186 arbitrary units Standard Error 0.109	-0.232 arbitrary units Standard Error 0.138	-0.178 arbitrary units Standard Error 0.139	-0.156 arbitrary units Standard Error 0.076	-0.226 arbitrary units Standard Error 0.057	-0.308 arbitrary units Standard Error 0.109
Contrast Sensitivity Week 4	-0.246 arbitrary units Standard Error 0.123	-0.366 arbitrary units Standard Error 0.144	-0.098 arbitrary units Standard Error 0.074	-0.433 arbitrary units Standard Error 0.079	-0.193 arbitrary units Standard Error 0.051	-0.386 arbitrary units Standard Error 0.135

Adverse Events

Optive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Soothe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

New Emulsion

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

William Ridder

Southern California College of Optometry

Phone: 714-449-7494

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60