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Study of ST266 Eye Drops in Treating Dry Eye

NCT02369861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-05-13

No results posted yet for this 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

  • Dry Eye Syndrome

Interventions

DRUG

ST266

Topical ocular application 4 times per day

DRUG

Refresh Lubricant Eye Drops

Topical ocular application 4 timer per day

Sponsors & Collaborators

  • U.S. Navy Bureau of Medicine

    collaborator UNKNOWN

  • Noveome Biotherapeutics, formerly Stemnion

    lead INDUSTRY

Principal Investigators

  • David Steed, MD · Noveome Biotherapeutics, formerly Stemnion

  • Kathy Kelley, OD · Price Vision Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02369861 on ClinicalTrials.gov