A Phase 1/2, RU-101 Ophthalmic Solution in Patients With Severe Dry Eye

NCT01843894 | Completed Phase 1 DMC

• 1 other identifier: RU-101-C001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Primary

• To determine the safety and tolerability of escalating doses of RU-101 for 4 weeks in patients with severe dry eye Secondary
• To explore the efficacy of RU-101
• To explore optimal endpoints for future studies

Conditions

Dry Eye

Keywords

sever dry eye,keratoconjunctivitis sicca

Outcome Measures

Primary Outcomes (1)

• Occular Adverse Events

  The number of participants with a change from baseline in the following symptoms: * intraocular pressure (IOP)-The IOP assessment will be done using either a Goldmann applanation tonometer or digital tonometer. * slit lamp biomicroscopy * fundoscopy-A dilated fundoscopic examination including evaluation of the vitreous, optic nerve, macula and retina will be performed and any abnormalities will be evaluated on a 4-point scale (1-4; slight, moderate, severe, or very severe

  56 dyas (stage1) 112 days (stage 2)

Secondary Outcomes (3)

• Symptoms

  28days (stage 1) 3 months (stage2)

• Signs

  28days (stage 1) 3 months (stage2)

• Non-Occular Adverse Events

  56 dyas (stage1) 112 days (stage 2)

Study Arms (2)

placebo

PLACEBO COMPARATOR

In Stage I, each patient will instill 1 drop of placebo into each eye, 6 times a day with at least 2 hours between each dose, for 28 days (4 weeks; a total of 168 doses to each eye). In Stage II, each patient will instill 1 drop into each eye, 6 times a day with at least 2 hours between each dose, for 84 days (12 weeks; a total of 504 doses to each eye).

Biological: RU-101

RU-101

EXPERIMENTAL

In Stage I, each patient will instill 1 drop of RU-101 ophthalmic solution (5%, 10%, or 15%) into each eye, 6 times a day with at least 2 hours between each dose, for 28 days (4 weeks; a total of 168 doses to each eye). In Stage II, each patient will instill 1 drop of RU-101 ophthalmic solution (selected dose from Stage I) into each eye, 6 times a day with at least 2 hours between each dose, for 84 days (12 weeks; a total of 504 doses to each eye).

Biological: RU-101

Interventions

RU-101 BIOLOGICAL

Recombinant human serum albumin

RU-101; placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 to 80 years.
• Patients have had dry eye symptoms at least 4 months.
• Patients have the following signs in the worst eye:
• Corneal staining score with fluorescein staining ≥ 6/15 with at least one in the central
• Conjunctival staining score with Lissamine Green ≥ 2/18
• Patients who had been receiving treatment with eye drops of artificial tears, Restasis, or topical steroids but have had insufficient efficacy or have found these products to be intolerable. If using Restasis or topical steroids, patients must agree to a 30-day washout period prior to the first IP dose (Day 0).
• Female patients of child bearing potential must agree to have a urine pregnancy test performed at Screening (must be negative) and agree to use a medically acceptable form of birth control (e.g., intrauterine device, birth control pill, patch or subcutaneous implant, condoms, diaphragm, or abstinence) throughout the duration of IP instillation. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for \> 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

You may not qualify if:

• Presence of anterior eye diseases except dry eye.
• Intraocular pressure ≥ 22 mmHg at Screening.
• Use of any ophthalmic solutions (including over-the-counter \[OTC\] solutions), serum eye drops, or contact lenses during the Treatment Phase. Artificial tears are allowed during the Screening Phase but must not be used from the first dose (Day 0) through the Treatment Phase.
• Use of eye drops of Restasis or topical steroids within 30 days of the first dose (Day 0).
• Use of antihistamines, beta blockers, tricyclic antidepressants, or antidepressants with anticholinergic side effects during the Treatment Phase.
• Patients with previous corneal transplantation or laser-assisted in situ keratomileusis (LASIK).
• Presence of graft-versus-host disease (GVHD).
• Patients who have had other ocular surgery within 3 months prior to the first dose.
• Patients with punctal plugs or punctal cautery \< 3 months prior to the first dose.
• Patients with severe dry eye due to Stevens-Johnson disease or ocular cicatricial pemphigoid.
• History of allergy to human serum protein products and/or any history of allergy to yeast.
• History of allergies to recombinant products, ophthalmic solutions, any constituents of RU 101, or any solutions planned for use in this study.
• Any significant chronic illness that, in the opinion of the Principal Investigator (PI), could interfere with the study parameters.
• Use of any investigational product or device within 30 days prior to the Screening Visit or during the study.
• Known history of alcohol and/or drug abuse within the past 12 months, which in the opinion of the PI could interfere with study compliance, outcome measures including safety parameters, and/or the general medical condition of the patient.

Sponsors & Collaborators

• R-Tech Ueno, Ltd.: lead

Study Sites (1)

Virginia Eye Consultants

Norfolk, Virginia, 22655-5342, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ruthenium-101

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• John Sheppard, MD

  Virginia Ehe Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

US (1)