Ocular Hypertension or Open-Angle Glaucoma MedDRA version: 14.1 Level: LLT Classification code 10022801 Term: Intraocular pressure System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: SYL040012
Pharmaceutical Form: Eye drops, solution
CAS Number: 1242615-29-7
Current Sponsor code: SYL040012
Other descriptive name: SYL040012
Concentration unit: mg/ml milligram(s)/milli
Sponsors
Sylentis S.A.U.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any clinical trial-related procedures. 2. Male and female subjects in good or fair general health as assessed by the investigator. 3. Age =18 years. 4. Previous history or newly diagnosed IOP (=21 mmHg) with or without open-angle glaucoma in both eyes. 5. Normal result, or result typical for open-angle glaucoma of the following assessments in both eyes or available results in writting within the last 3 months prior to baseline period i.e. up to 4 months before Day 1, on condition that no new ocular signs or symptoms (e.g. marked deterioration of vision, eye pain) has occurred since then which would justify a repeat examination: - Visual field 24-2 or equivalent (24-2 Humphrey visual field SITA test, about 5 minutes per eye). - Optical coherence tomography (OCT). - Best corrected visual acuity =0.5 (20/40) on the Snellen chart, or =0.3 logMAR. - Schirmer test (lacrimation). - Funduscopy. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30 ;Inclusion criteria: 1. Signed informed consent prior to any clinical trial-related procedures. 2. Male and female subjects in good or fair general health as assessed by the investigator. 3. Age =18 years. 4. Previous history or newly diagnosed IOP (=21 mmHg) with or without open-angle glaucoma in both eyes. 5. Normal result, or result typical for open-angle glaucoma of the following assessments in both eyes or available results in writting within the last 3 months prior to baseline period i.e. up to 4 months before Day 1, on condition that no new ocular signs or symptoms (e.g. marked deterioration of vision, eye pain) has occurred since then which would justify a repeat examination: - Visual field 24-2 or equivalent (24-2 Humphrey visual field SITA test, about 5 minutes per eye). - Optical coherence tomography (OCT). - Best corrected visual acuity =0.5 (20/40) on the Snellen chart, or =0.3 logMAR. - Schirmer test (lacrimation). - Funduscopy. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Exclusion criteria related to general health 1. Pregnant or breastfeeding females or females with a positive urine pregnancy test at the baseline period and on Day 1 of the treatment period. 2. Females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until after the follow-up visit. • Females of childbearing potential are defined as females who are not post menopausal (amenorrheic without an alternative medical cause) or have not been irreversibly surgical sterilised by hysterectomy, bilateral oophorectomy or bilateral salpingectomy. • Medically acceptable contraceptive methods include vasectomised sexual partner, tubal occlusion, intrauterine device (copper banded coils only), intrauterine system (for example, Mirena), Depo-Provera, implants (Implanon, Norplan), normal and low dose combined oral pills, ethinylestradiol transdermal system (Evra Patch), and intravaginal device (NuvaRing). True sexual abstinence (starting from enrolment until after the follow-up visit) is also an acceptable contraceptive method. 3. Any current disease or condition that might compromise the respiratory, cardiovascular, endocrine, neurological, haematological, renal, or gastrointestinal function (unless deemed not clinically significant by the investigator and sponsor) such as, but not limited to, uncontrolled arterial hypertension (defined as systolic blood pressure [SBP] >160 mmHg or diastolic blood pressure [DBP] >95 mmHg with or without treatment), acute infection in any of the above mentioned systems, uncontrolled type 1 or type 2 diabetes (defined as persistently varying glucose values, receiving multiple insulin injections per day), bronchial asthma requiring frequent use of corticosteroids, or heart failure (New York Heart Association [NYHA] =grade 2). 4. Past history of a chronic or recurring condition that could interfere with treatment according to the investigator’s judgement. History of cancer in the last 5 years (except for cutaneous basal or squamous cell carcinoma resolved by excision). 5. Body temperature (axillary, oral or external auditory canal) =37.5°C (only to be checked at the enrolment visit). 6. Intolerability of any components of SYL040012 or placebo. 7. Unable to comply with the clinical trial requirements as judged by the investigator. Exclusion criteria related to medications or procedures 8. Beta blockers or corticosteroids (other than cutaneous or intra-articular) for the treatment of concurrent diseases, even if sporadically, or any ocular or nasal vasoconstrictor treatment in the last 15 days prior to the first investigational product administration 9. Previous refractive surgery; cataract extraction in the last 6 months. 10. Previous surgery for glaucoma. 11. Participation in a clinical trial within 2 months before the enrolment visit. 12. Use of any other investigational product within 60 days before the enrolment visit. 13. Other drugs for the treatment of concurrent diseases are allowed. However, their dosages should be kept constant throughout the study. Exclusion criteria related to ocular conditions 14. Use of contact lenses in the last 7 days prior to the first investigational product administration and wearing contact lenses throughout the trial. 15. History of ocular infection or inflammation within the last 3 months before the enrolment visit. 16. Pachymetry result (in the middle of the cornea) >620 micron or 160 mmHg or diastolic blood pressure [DBP] >95 mmHg with or without treatment), acute infection in any of the above mentioned systems, uncontrolled type 1 or type 2 diabetes (defined as persistently varying glucose values, receiving multiple insulin injections per day), bronchial asthma requiring frequent use of corticosteroids, or heart failure (New York Heart Association [NYHA] =grade 2). 4. Past history of a chronic or recurring condition that could interfere with treatment according to the investigator’s judgement. History of cancer in the last 5 years (except for cutaneous basal or squamous cell carcinoma resolved by excision). 5. Body temperature (axillary, oral or external auditory canal) =37.5°C (only to be checked at the enrolment visit). 6. Intolerability of any components of SYL040012 or placebo. 7. Unable to comply with the clinical trial requirements as judged by the investigator. Exclusion criteria related to medications or procedures 8. Beta blockers or corticosteroids (other than cutaneous or intra-articular) for the treatment of concurrent diseases, even if sporadically, or any ocular or nasal vasoconstrictor treatment in the last 15 days prior to the first investigational product administration 9. Previous refractive surgery; cataract extraction in the last 6 months. 10. Previous surgery for glaucoma. 11. Participation in a clinical trial within 2 months before the enrolment visit. 12. Use of any other investigational product within 60 days before the enrolment visit. 13. Other drugs for the treatment of concurrent diseases are allowed. However, their dosages should be kept constant throughout the study. Exclusion criteria related to ocular conditions 14. Use of contact lenses in the last 7 days prior to the first investigational product administration and wearing contact lenses throughout the trial. 15. History of ocular infection or inflammation within the last 3 months before the enrolment visit. 16. Pachymetry result (in the middle of the cornea) >620 micron or <500 micron. 17. Angle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Tolerability in the ocular surface (cornea and conjunctiva) and effect on intraocular pressure after a daily dose of the investigational product during 14 days of treatment;Secondary Objective: • Local tolerability after each dose. • Systemic tolerability: Effect on laboratory parameters, physical examination, vital signs and electrocardiogram. • Changes (if any) of the ocular fundus or visual acuity possibly related to the investigational product. ;Primary end point(s): Local tolerability: Includes simple corneal and conjunctival evaluation without corneal endothelium assessment or pachymetry. A slit lamp will be used. The local tolerability evaluation will include: Cornea: Corneal epithelium using fluorescein and Bengal pink dye. Conjunctiva: Palpebral and bulbar conjunctival hyperaemia. A VAS will be used to assess local tolerability in case of symptoms: 0 = no ocular discomfort and 100 = severe ocular discomfort. The tolerability variable can be categorised as: Normal: No corneal or conjunctival alteration observed. Grade 1: Symptomatic or minimally symptomatic alterations observed, but which do not require intervention or interfere with function. Grade 2: Symptomatic alterations observed which interfere with the function but not with daily life, and require topical intervention. Grade 3: Symptomatic alterations observed which interfere with daily life, and require surgical intervention. This classification is based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 ;Timepoint(s) of evaluation of this end point: Continuously during the whole trial and in a daily basis: days 1 to 15 and in the follow-up visit/early termination visit days.;Main Objective: Tolerability in the ocular surface (cornea and conjunctiva) and effect on intraocular pressure after a daily dose of the investigational product during 14 days of treatment;Secondary Objective: • Local tolerability after each dose. • Systemic tolerability: Eff | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Anterior segment of the eye • Visual acuity • Ocular fundus • Physical examination and vital signs • Laboratory analyses (haematology, biochemistry, and urinalysis) • 12-Lead ECG • Recording of AEs • VAS of local tolerability in case of symptoms (0 = no ocular discomfort and 100 = severe ocular discomfort). ;Timepoint(s) of evaluation of this end point: Continuously during the whole trial.;Secondary end point(s): • Anterior segment of the eye • Visual acuity • Ocular fundus • Physical examination and vital signs • Laboratory analyses (haematology, biochemistry, and urinalysis) • 12-Lead ECG • Recording of AEs • VAS of local tolerability in case of symptoms (0 = no ocular discomfort and 100 = severe ocular discomfort). ;Timepoint(s) of evaluation of this end point: Continuously during the whole trial. | — |
Countries
Estonia, Germany, Spain
Contacts
Public ContactHead of Regulatory Affairs & QP;Head of Regulatory Affairs & QP ;
Sylentis S.A.U.;Sylentis S.A.U.
Outcome results
None listed