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NCT02369861 · ClinicalTrials.gov registry record · Phase 1

Study of ST266 Eye Drops in Treating Dry Eye

A Phase 1 study of Dry Eye Syndrome, sponsored by Noveome Biotherapeutics, formerly Stemnion.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT02369861 is a Phase 1 study of Dry Eye Syndrome that has completed, run by Noveome Biotherapeutics, formerly Stemnion. The registered enrollment target is 30 participants, below the 162-participant average among 10 other Dry Eye Syndrome trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02369861, a Phase 1 study of Dry Eye Syndrome, has completed, sponsored by Noveome Biotherapeutics, formerly Stemnion.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history, ophthalmic examination to include the status of their ocular structure and function and evaluation of tear production. Blood will be blood drawn for complete blood count and chemistry panel. They will also have a urinalysis and pregnancy test in women of child-bearing potential. Subjects will have a two week "run-in" period in which they use artificial tears. If their Dry Eye signs and symptoms do not improve significantly, they will be enrolled and will receive study drug. Safety evaluation includes assessment of the structure and function of the eyes including retina examination and corrected visual acuity. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, ST266 or "artificial tears" eye drops. The randomization scheme is 1:1 ST266:artificial tears. Subjects will self-administer their eye drops four times each day. Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each visit. The baseline eye tests and lab work will be repeated after the treatment phase of the study at the end of week six. Following 6 weeks of treatment, the subjects will be followed for 4 additional weeks.

Conditions Studied

Dry Eye Syndrome

Interventions

  • DRUG ST266
  • DRUG Refresh Lubricant Eye Drops

Study Locations (1)

Indiana

  • Price Vision Group - Indianapolis

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-03
Est. Completion 2015-12
Phase Phase 1

Sponsor

Noveome Biotherapeutics, formerly Stemnion

12 total trials

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What the Registry Record Tells You About NCT02369861

The ClinicalTrials.gov registry entry for NCT02369861 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 162-participant average among 10 other Dry Eye Syndrome trials with a reported enrollment target (81% lower). The listed sponsor is Noveome Biotherapeutics, formerly Stemnion, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Dry Eye Syndrome appearing as the primary indexed condition, and to 2 interventions - of which ST266 is the first listed.

NCT02369861 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT02369861 about?

NCT02369861 is a clinical study titled "Study of ST266 Eye Drops in Treating Dry Eye". Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history, ophthalmic examination to include the status of their ocular structure and function and evaluation of tear production. Blood will be blood drawn for complete blood count and chemistry panel. They will also have ...

What is the current status of trial NCT02369861?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-03. Estimated completion is 2015-12.

What conditions does trial NCT02369861 study?

This clinical trial studies the following conditions: Dry Eye Syndrome.

What interventions are being tested in trial NCT02369861?

The interventions under investigation include: ST266 (DRUG), Refresh Lubricant Eye Drops (DRUG).

Who is sponsoring clinical trial NCT02369861?

This trial is sponsored by Noveome Biotherapeutics, formerly Stemnion, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02369861 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.