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Dry EyePhase 1/2NCT01843894

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

A Phase 1/2 study testing RU-101 in people with Dry Eye, run by R-Tech Ueno, Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Dry Eye
What is being tested?
RU-101
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 siteUnited States
Study dates
Apr 2013to Jul 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Eye Consultants

    Norfolk, Virginia, 22655-5342

Other trials in United States

About this study

Official title: A Phase 1/2, First-in-Human, Double-Masked, Placebo-Controlled, Dose-Escalation Study Evaluating the Safety, Tolerability, and Efficacy of RU-101 Ophthalmic Solution in Patients With Severe Dry Eye

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
Read the detailed description

This is a Phase 1/2, first-in-human, multicenter, dose escalation, double-masked, placebo controlled study consisting of two stages. In Stage I, 3 cohorts are planned to evaluate escalating doses of RU 101 ophthalmic solution, instilled 6 times daily into each eye for 4 weeks (28 days). Each cohort will comprise 4 patients randomized 3:1 to RU-101 or placebo. A masked safety data review will be performed prior to each dose escalation to determine if any dose limiting toxicities (DLTs) occurred and to define the MTD or highest dose to be used in Stage II. In Stage II, an expanded cohort will receive the dose defined in Stage I (MTD or highest dose if MTD is not reached), instilled 6 times daily into each eye for 12 weeks (84 days). The expanded cohort will comprise approximately 96 patients randomized 1:1 to RU-101 or placebo, provided in a double-masked manner.

Conditions
Dry Eye
Being tested
RU-101
Keywords
sever dry eye,keratoconjunctivitis sicca
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RU-101Biological

    Recombinant human serum albumin

Study groups in NCT01843894
Study groupRoleWhat they receive
placeboPlacebo comparatorIn 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).
Receives: Biological: RU-101
RU-101ExperimentalIn 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).
Receives: Biological: RU-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 56 dyas (stage1) 112 days (stage 2)

Secondary outcomes (3)

  1. Symptoms

    The number of participants with a change from baseline in the following symptoms:

    • Symptom Assessment in Dry Eye (SANDE)
    • Ocular Surface Disease Index (OSDI)
    • Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] chart, high and 10% low contrast)

    Measured: 28days (stage 1) 3 months (stage2)

  2. Signs

    The number of participants with a change from baseline in the following signs:

    • Tear break-up time (TBUT)
    • Corneal staining with fluorescein
    • Conjunctival staining with Lissamine Green
    • Corneal sensitivity
    • Schirmer test

    Measured: 28days (stage 1) 3 months (stage2)

  3. Non-Occular Adverse Events

    Number of AEs will be measured (vital signs, physical examination results, safety laboratory results, 12-lead electrocardiogram (ECG), and IP comfort assessment.

    Measured: 56 dyas (stage1) 112 days (stage 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843894
Sponsor's protocol ID
RU-101-C001
Status last verified
Sep 2019
First submitted
12 Apr 2013
Last updated
11 Sep 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RU-101 in people with Dry Eye, run by R-Tech Ueno, Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occular Adverse Events (time frame: 56 dyas (stage1) 112 days (stage 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843894.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.

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