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Study of ST266 Eye Drops in Treating Dry Eye
NCT02369861 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02369861
The ClinicalTrials.gov registry entry for NCT02369861 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Noveome Biotherapeutics, formerly Stemnion, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02369861 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02369861?
The interventions under investigation include: ST266 (DRUG), Refresh Lubricant Eye Drops (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02369861?
This trial is sponsored by Noveome Biotherapeutics, formerly Stemnion, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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