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CompletedNCT01346371Updated Mar 31, 2020Results posted

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

A Phase 4 interventional study of Refresh Tears 0.5% Lubricant Eye Drops and Bepreve 1.5% Ophthalmic Solution in Allergic Conjunctivitis, sponsored by Minnesota Eye Consultants, P.A.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by Minnesota Eye Consultants, P.A. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.

Read the detailed description

This is a single-center, randomized, parallel group, placebo-controlled study to evaluate the effect of BEPREVE compared to a placebo eye drop on the measurement of tear film osmolarity and tear film lipid layer in patients with allergic conjunctivitis.

Subjects will be screened for this study on day one of dosing with the test article. Subjects who sign the informed consent form and who meet all inclusion/exclusion criteria will be eligible for participation in this study. They will be assigned sequentially, according to a computer generated randomization list, in a ratio of 1:1 to receive either BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% or REFRESH TEARS® Lubricant Eye Drops (1:1). Subjects will instill one drop of test article either BEPREVE™ or REFRESH TEARS® into the study eyes twice daily for a maximum of 60 days. Subjects will be seen for evaluation on Days 0, 28±3, and 56±3 following randomization.

02

Conditions studied

  • Allergic Conjunctivitis

Keywords

  • Allergic
  • conjunctivitis
  • Allergic conjunctivitis
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Minnesota Eye Consultants, P.A. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
  2. Have documented positive skin prick puncture test to at least one (1) seasonal allergen (e.g., grasses, trees, weeds, or other allergens) within two (2) years of Visit 1.
  3. Agree not to have any other ocular drops in study eyes within 2 days prior to the initiation of dosing with the test article or throughout the duration of the study.
  4. Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
  5. Are willing/able to follow instructions from the study investigator and his/her staff.
  6. Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff.
  7. Are able to self-administer test article (or have a caregiver available to instill all doses of test article).
  8. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion criteria

Exclusion Criteria:

  1. Have known hypersensitivity to either BEPREVE™ or REFRESH TEARS® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
  2. Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.
  3. Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
  4. Have a history of abuse of alcohol/drugs within six months prior to the screening visit.
  5. Are pregnant or nursing/lactating.
  6. Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    Refresh Tears® eye drops

    Must add drops twice a day every day during trial enrollment.

    Drug: Bepreve 1.5% Ophthalmic Solution

  • Experimental
    Bepreve® 1.5% solution

    Must add drops twice a day every day while enrolled in trial.

    Drug: Refresh Tears 0.5% Lubricant Eye Drops

Interventions

  • DrugRefresh Tears 0.5% Lubricant Eye Drops
  • DrugBepreve 1.5% Ophthalmic Solution
06

What researchers measure

Primary outcomes

  1. Tear Osmolarity

    The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.

    Time frame: 56 days after initial screening visit

07

Results

Posted Mar 31, 2020

Participant flow

Recruitment began Aug 15, 2011 and concluded June 11, 2012. There are a variety of sources we recruited our subjects from which is outlined below: Email. PI referrals, employee, and subject referrals. Flyers posted around college campuses. Website clinicaltrial.gov.

Participant flow — Overall Study
MilestoneRefresh Tears® Eye DropsBepreve® 1.5% Solution
Started2020
Completed1820
Not completed20
Withdrew: Lost to follow-up20

Outcome measures

PrimaryTear Osmolarity

The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.

Time frame:
56 days after initial screening visit
Reported as:
Mean · mOsM/L
Tear Osmolarity
mOsM/LRefresh Tears® Eye DropsBepreve® 1.5% Solution
Tear Osmolarity303 ± 3.13303 ± 2.57

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Refresh Tears® Eye Drops—0/20 (0%)10/20 (50%)
Bepreve® 1.5% Solution—0/20 (0%)14/20 (70%)
Most frequent other events
Most frequent other events
EventRefresh Tears® Eye DropsBepreve® 1.5% Solution
Ocular itchingEye disorders8/207/20
Cold like symptomsGeneral disorders7/204/20
Bad Taste in mouthGeneral disorders0/207/20
Ocular BurningEye disorders5/204/20
Ocular IrritationEye disorders2/201/20
Stomach problemsGastrointestinal disorders1/202/20
General eye discomfortEye disorders1/201/20
Joint/muscle painMusculoskeletal and connective tissue disorders1/201/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Refresh Tears® Eye DropsBepreve® 1.5% SolutionTotal
<=18 years000
Between 18 and 65 years202040
>=65 years000
Age, Continuous
Age, Continuous(years)Refresh Tears® Eye DropsBepreve® 1.5% SolutionTotal
Mean40 ± 1335 ± 1238 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)Refresh Tears® Eye DropsBepreve® 1.5% SolutionTotal
Female151025
Male51015
Region of Enrollment
Region of Enrollment(participants)Refresh Tears® Eye DropsBepreve® 1.5% SolutionTotal
United States202040
08

Study locations

1 site
  • Minnesota Eye Consultants, P.A.
    Minneapolis, Minnesota 55404, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01346371
Lead sponsor
Minnesota Eye Consultants, P.A.
Collaborators
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
May 3, 2011
Start date
May 2011
Primary completion
Aug 2012
Completion
Sep 2012
Results posted
Mar 31, 2020
Last update
Mar 31, 2020

Study contacts

Ahmad M Fahmy, O.D.
principal investigator · Minnesota Eye Consultants

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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