Study of ST266 Eye Drops in Treating Dry Eye

NCT02369861 | Completed Phase 1

• 1 other identifier: ST-05-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Corneal staining with fluorescein

  National Eye Institute Scoring System: 0=none, 1=mild, 2=moderate, 3=severe

  Change in degree of staining at 6 weeks

Secondary Outcomes (6)

• Lissamine staining

  Change in degree of staining from baseline at 6 weeks

• Endothelial cell count

  Change from baseline at 6 weeks

• Intraocular pressure

  Change in pressure from baseline at 6 weeks

• Tear volume

  Change in tear volume from baseline at 6 weeks

• Assessment of structure and function of the eye

  Change from baseline at 6 weeks

Other Outcomes (1)

• Tear osmolarity

  Change from baseline at 6 weeks

Study Arms (2)

ST266

EXPERIMENTAL

Eye drops

Drug: ST266

Artificial tears

PLACEBO COMPARATOR

Refresh lubricant eye drops

Drug: Refresh Lubricant Eye Drops

Interventions

ST266 DRUG

Topical ocular application 4 times per day

ST266

Refresh Lubricant Eye Drops DRUG

Topical ocular application 4 timer per day

Artificial tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ages 18 years and older.
• Subjects with symptoms and signs of Dry Eye for \> four months supported by previous clinical diagnosis or self-reported history.
• Visual acuity corrected 20/40 or better in each eye.
• If wearing contact lenses, subjects must be willing to refrain from wearing the contact lenses during the study (including washout period).
• Score of 25-75 on the Ocular Surface Disorder Index (OSDI) questionnaire.
• Corneal staining of grade 2 or more anywhere on the cornea (scale 0-4).

You may not qualify if:

• Pregnant or breast feeding.
• Anterior segment disease other than Dry Eye which in the opinion of the investigator would confound the study.
• Macular and neovascular eye diseases
• History of corneal surgery or LASIK (laser in situ keratomileusis) surgery in either eye within the past year.
• Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication (except for artificial tears) or experimental drug within the past 30 days.
• Subjects with glaucoma or in whom glaucoma is suspected.
• Use of anticholinergic drugs, antihistamines, beta-blockers, or tricyclic anti-depressants within the past 30 days.
• Asymmetric punctal plugs or punctal cauterization within the past three months.
• History of Stevens-Johnson disease, ocular cicatricial pemphigoid, alkali burn of the eye, or graft-versus-host disease.
• Immune compromise for any reason.
• Kidney or liver function studies \>2x the upper limit of normal.
• Symptomatic abnormalities od the lid.
• History of cancer within the past 5 years

Sponsors & Collaborators

• Noveome Biotherapeutics, formerly Stemnion: lead
• U.S. Navy Bureau of Medicine: collaborator

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• David Steed, MD

  Noveome Biotherapeutics, formerly Stemnion

  STUDY DIRECTOR

• Kathy Kelley, OD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: February 24, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

US (1)