R-Tech RU-101 Ophthalmic Solution in Patients with severe dry eye

Overview

Status: Recruiting
Keywords: Dry eye
IRB Number: 00066755
Specialty: Ophthalmology, Ophthalmology
Sub Specialties: Comprehensive Ophthalmology, Cornea

Brief Summary

This is a Phase 1/2, double-masked, dose-escalating study of RU-101 ophthalmic solution in

patients with severe dry eye. The primary goal is to evaluate safety and tolerability of repeated

instillation of RU-101, but effects on signs and symptoms of dry eye will also be evaluated.

Stage I of the study is designed to determine the maximum tolerated dose (MTD). Stage II will

better define the safety, tolerability, and efficacy of the dose selected in Stage I.

 

Objectives:

Stage I

Primary

To determine the safety and tolerability of escalating doses of RU-101 for 4 weeks in patients with

severe dry eye

Secondary

To determine the maximum tolerated dose (MTD)

To explore the efficacy of RU-101

Stage II

Primary

To determine the safety and tolerability of RU-101 for 12 weeks in patients with severe dry eye

Secondary

To explore the efficacy of RU-101

To explore optimal endpoints for future studies

Principal Investigator: Nick Mamalis
Department: Ophthalmology-Services
Co Investigator:

Contact Information

Name:Susan Allman
Phone: 801-581-5142
Email: susan.allman@hsc.utah.edu

Inclusion Criteria

Each patient must meet the following criteria at Screening to be enrolled in the study:

1. Male or female patients aged 18 years old and older.

2. Patients have had dry eye symptoms at least 4 months.

3. Patients have the following signs in the worst eye:

a. Corneal staining score with fluorescein staining 6/15 with at least one in the

central

b. Conjunctival staining score with Lissamine Green 2/18.

4. 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).

5. 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).

Exclusion Criteria

Patients who meet any of the following criteria at Screening will be excluded from the study:

1. Presence of anterior eye diseases except dry eye.

2. Intraocular pressure 22 mmHg at Screening.

3. 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.

4. Use of eye drops of Restasis or topical steroids within 30 days of the first dose (Day 0).

5. Use of antihistamines or tricyclic antidepressants during the Treatment Phase. (Topical antihistamines for dermatological use are allowed during the study and systemic beta blockers and antidepressants (as long as stable doses during the study) other than tricyclic antidepressants are allowed in Stage II.)

6. Patients with previous corneal transplantation, kerato-refractive surgery, or laser-assisted in

situ keratomileusis (LASIK).

7. Presence of graft-versus-host disease (GVHD).

8. Patients who have had other ocular surgery within 3 months prior to the first dose.

9. Patients with punctal plugs or punctal cautery < 3 months prior to the first dose.

10. Patients with severe dry eye due to Stevens-Johnson disease or ocular cicatricial

pemphigoid.

11. History of allergy to human serum protein products and/or any history of allergy to yeast.

12. History of allergies to recombinant products, ophthalmic solutions, any constituents of

RU-101, or any solutions planned for use in this study.

13. Any significant chronic illness that, in the opinion of the Principal Investigator (PI), could

interfere with the study parameters.

14. Use of any investigational product or device within 30 days prior to the Screening Visit or

during the study.

15. 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.

16. Those unable in the opinion of the PI to comply fully with the study requirements.