Trial · NCT01346371

The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer

NCT01346371, Phase 4, Completed, Minnesota Eye Consultants, P.A.; results first posted 2020-03-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer. Trials, record NCT01346371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01346371

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
NCT number: NCT01346371
Status: Completed
Phases: Phase 4
Enrollment: 40 participants, actual
Lead sponsor: Minnesota Eye Consultants, P.A.
Conditions: Allergic Conjunctivitis
Interventions: Refresh Tears 0.5% Lubricant Eye Drops, Bepreve 1.5% Ophthalmic Solution
First posted: 2011-05-03
Last updated: 2020-03-31
Results first posted: 2020-03-31

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Tear Osmolarity	56 days after initial screening visit	The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Tear Osmolarity	56 days after initial screening visit	Analysis per protocol as ITT and LOCF for all subject eyes.	mOsM/L	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Tear Osmolarity	Refresh Tears® Eye Drops		303	Standard Deviation 3.13	mOsM/L
Tear Osmolarity	Bepreve® 1.5% Solution		303	Standard Deviation 2.57	mOsM/L

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Refresh Tears® Eye Drops	20
Overall Study	STARTED	Bepreve® 1.5% Solution	20
Overall Study	COMPLETED	Refresh Tears® Eye Drops	18
Overall Study	COMPLETED	Bepreve® 1.5% Solution	20
Overall Study	NOT COMPLETED	Refresh Tears® Eye Drops	2
Overall Study	NOT COMPLETED	Bepreve® 1.5% Solution	0

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Ocular Irritation	Eye disorders	Refresh Tears® Eye Drops	2	20	2
other	Ocular Irritation	Eye disorders	Bepreve® 1.5% Solution	1	20	1
other	Ocular Burning	Eye disorders	Refresh Tears® Eye Drops	5	20	5
other	Ocular Burning	Eye disorders	Bepreve® 1.5% Solution	4	20	4
other	Ocular itching	Eye disorders	Refresh Tears® Eye Drops	8	20	9
other	Ocular itching	Eye disorders	Bepreve® 1.5% Solution	7	20	7
other	Cold like symptoms	General disorders	Refresh Tears® Eye Drops	7	20	7
other	Cold like symptoms	General disorders	Bepreve® 1.5% Solution	4	20	5
other	Stomach problems	Gastrointestinal disorders	Refresh Tears® Eye Drops	1	20	1
other	Stomach problems	Gastrointestinal disorders	Bepreve® 1.5% Solution	2	20	2

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Refresh Tears® Eye Drops
Total, all-cause mortality	Bepreve® 1.5% Solution
Total, other adverse events	Refresh Tears® Eye Drops	10	20
Total, other adverse events	Bepreve® 1.5% Solution	14	20
Total, serious adverse events	Refresh Tears® Eye Drops	0	20
Total, serious adverse events	Bepreve® 1.5% Solution	0	20

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Refresh Tears® Eye Drops vs Bepreve® 1.5% Solution: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01346371

GET https://conductscience.org/api/trials/v1/NCT01346371/registered

API reference For AI assistants