SYLTAG (SYL040012, Treatment for open Angle Glaucoma)

• Register: EUCTR
• Last refreshed on: 12 October 2015
• Main ID: EUCTR2013-002947-27-ES
• Date of registration: 06/08/2014
• Prospective Registration: Yes
• Primary sponsor: Sylentis S.A.U.
• Public title: SYLTAG (SYL040012, Treatment for open Angle Glaucoma)
• Scientific title: A phase II, observer masked, active controlled study of SYL040012 for the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension (SYLTAG) - SYLTAG
• Date of first enrolment: 20/08/2014
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002947-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 5

Countries of recruitment

Estonia, Germany, Spain, United States

Contacts

• Name: Head of Regulatory Affairs & QP
• Affiliation: SYLENTIS S.A.U

• Name: Head of Regulatory Affairs & QP
• Affiliation: SYLENTIS S.A.U

Key inclusion & exclusion criteria

Inclusion criteria:
Age ?18 years.
Male and female subjects in good or fair general health as assessed by the investigator.
Signed informed consent prior to any clinical trial-related procedures.
Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
Unmedicated (post-washout) IOP ? 23 mmHg as the mean value of all the assessments performed at 09:00, 12:00, and 15:00 hours at baseline, in the worst eye that must not have a difference greater than 3 mmHg with respect to the other eye.
Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
Central corneal thickness 480-620 ?m in the study eye.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion criteria:
Pregnant or breastfeeding females or females with a positive pregnancy test at screening or baseline visits.
Females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until after the follow-up visit. Medically acceptable contraceptive methods include vasectomised sexual partner, tubal occlusion, intrauterine devices or implants, normal or low dose combination oral pills, ethinylestradiol transdermal system, and intravaginal devices. True sexual abstinence (starting from enrollment until after the follow-up visit) is also an acceptable contraceptive method.
Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
Known hypersensitivity to any component of the formulations (benzalkonium chloride, etc.), or to topical anesthetics or Timolol maleate or other beta-blocking agents.
Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline-directed therapy) or severe chronic obstructive pulmonary disease; sinus bradycardia, second and third-degree AV block, overt cardiac failure, cardiogenic shock and any other Systemic disease non compatible with the use of Timolol according its current version of the Summary of Product Characteristics.
Severe visual field defect. Presence of a scotoma within 5° of fixation on visual field examination.
Any secondary glaucoma or Ocular hypertension (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
IOP ? 35 mm Hg in any eye at any of the assessment at 09:00, 12:00, and 15:00 hrs, or mean IOP < 21 mmHg at baseline.
Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser trabeculoplasty) and refractive surgery.
Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6 months prior to Baseline.
Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis
Ocular medication of any kind within 30 days of Visit 0, with the exception of ocular hypotensive medications (which must be washed out according to the provided schedule, see 7.2.3.1) lib scrubs or lubricating drops for dry eye (which may be used until V0); and the use of systemic beta-blockers within 7 days of Visit 0.
Clinically significant ocular disease (e.g. uveitis, severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial erosions of the cornea, and/or use of dry eye medication [including artificial tears] with a frequency exceeding 8 instillations per day). which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
Any abnormality preventing reliable applanation tonometry of either eye.
Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
Participation in any investigational study within 30 days prior to screening.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Open angle glaucoma - intraocular pressure
MedDRA version: 17.0 Level: LLT Classification code 10022801 Term: Intraocular pressure System Organ Class: 100000004848

Intervention(s)

Product Name: SYL040012
Pharmaceutical Form: Eye drops
INN or Proposed INN: Bamosiran
CAS Number: 1242615-29-7
Other descriptive name: SYL040012
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.375-

Product Name: SYL040012
Pharmaceutical Form: Eye drops
INN or Proposed INN: Bamosiran
CAS Number: 1242615-29-7
Other descriptive name: SYL040012
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.75-

Product Name: SYL040012
Pharmaceutical Form: Eye drops
INN or Proposed INN: Bamosiran
CAS Number: 1242615-29-7
Other descriptive name: SYL040012
Concentration unit: % percent
Concentration type: equal
Concentration number: 1.125-

Product Name: SYL040012
Pharmaceutical Form: Eye drops
INN or Proposed INN: Bamosiran
CAS Number: 1242615-29-7
Other descriptive name: SYL040012
Concentration unit: % percent
Concentration type: equal
Concentration number: 1.5-

Trade Name: Timolol maleate
Pharmaceutical Form: Eye drops
INN or Proposed INN: Timolol Maleate
Other descriptive name: TIMOLOL MALEATE
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)

Primary end point(s): The absolute change in mean diurnal IOP after 28 days of treatment

Secondary Objective: Comparative effect on changes within each treatment group in the mean diurnal IOP value after 14 days of treatment (D14) vs baseline.
The comparison in the mean diurnal IOP changes vs. the active control (Timolol) after 14 and 28 days will be also done.
Changes from baseline in the Glaucoma Quality of Life questionnaire (GQL-15) at the end of the study.
The safety variables are the local and systemic tolerability (comparison after 28 days of treatment vs. screening or baseline, based on when the last pre-treatment assessment was done)

Main Objective: To determine the most effective drug concentration of SYL040012 in the reduction of the intraocular pressure (IOP) after 28 days of treatment.

Timepoint(s) of evaluation of this end point: The mean diurnal IOP will be assessed as the mean value of the assessments at 09:00, 12:00 and 15:00, both at baseline and after 28 days.

Secondary Outcome(s)

Secondary end point(s): - The changes in the mean diurnal IOP value after 14 days of treatment
- The comparison in the mean diurnal IOP change vs. the active control (Timolol) will be also done after 14 and 28 days of treatment
- Changes to the GQL-15 questionnaire.
--Safety objectives will include the assessment of the effect of the treatment on the following parameters:
? VAS of local tolerability (ocular discomfort)
? Visual acuity
? Biomicroscopy
? Pachymetry
? Ophthalmoscopy
? Systemic tolerability:
o Physical examination
o Vital signs
o Laboratory parameters
o Electrocardiogram
? Adverse Events (AEs).

Timepoint(s) of evaluation of this end point: Continuosly during the whole trial

Secondary ID(s)

2013-002947-27-EE

SYL040012_IV

Source(s) of Monetary Support

Sylentis S.A.U