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
The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.
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.
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 →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.
Exclusion Criteria:
Must add drops twice a day every day during trial enrollment.
Drug: Bepreve 1.5% Ophthalmic Solution
Must add drops twice a day every day while enrolled in trial.
Drug: Refresh Tears 0.5% Lubricant Eye Drops
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
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.
| Milestone | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution |
|---|---|---|
| Started | 20 | 20 |
| Completed | 18 | 20 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.
| mOsM/L | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution |
|---|---|---|
| Tear Osmolarity | 303 ± 3.13 | 303 ± 2.57 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Refresh Tears® Eye Drops | — | 0/20 (0%) | 10/20 (50%) |
| Bepreve® 1.5% Solution | — | 0/20 (0%) | 14/20 (70%) |
| Event | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution |
|---|---|---|
| Ocular itchingEye disorders | 8/20 | 7/20 |
| Cold like symptomsGeneral disorders | 7/20 | 4/20 |
| Bad Taste in mouthGeneral disorders | 0/20 | 7/20 |
| Ocular BurningEye disorders | 5/20 | 4/20 |
| Ocular IrritationEye disorders | 2/20 | 1/20 |
| Stomach problemsGastrointestinal disorders | 1/20 | 2/20 |
| General eye discomfortEye disorders | 1/20 | 1/20 |
| Joint/muscle painMusculoskeletal and connective tissue disorders | 1/20 | 1/20 |
| Age, Categorical(Participants) | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 20 | 40 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | Total |
|---|---|---|---|
| Mean | 40 ± 13 | 35 ± 12 | 38 ± 13 |
| Sex: Female, Male(Participants) | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | Total |
|---|---|---|---|
| Female | 15 | 10 | 25 |
| Male | 5 | 10 | 15 |
| Region of Enrollment(participants) | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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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Minnesota Eye Consultants, P.A.