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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: Completed Phase 1 study of Dry Eye Syndrome, sponsored by Noveome Biotherapeutics, formerly Stemnion.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
National Eye Institute Scoring System: 0=none, 1=mild, 2=moderate, 3=severe
Conditions Studied
Interventions
- DRUG ST266
- DRUG Refresh Lubricant Eye Drops
Study Locations (1)
Indiana
- Price Vision Group - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT02369861 record still lists
NCT02369861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 162-participant average among 10 other Dry Eye Syndrome trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Dry Eye Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02369861's enrollment target sits among peer trials
30 8th of 10 higher than 3 of 10 other Dry Eye Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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