Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT) MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Code: DE-126
Pharmaceutical Form: Eye drops, suspension in single-dose container
INN or Proposed INN: Sepetaprost
CAS Number: 1262873-06-2
Current Sponsor code: DE-126
Other descriptive name:
Sponsors
SANTEN INCORPORATED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF). 2. Be 18 years of age or older on the date of signing the ICF and be able and willing to comply with all treatment and follow-up study procedures. 3. If a subject is a female of childbearing potential (i.e., not post-menopausal [within 12 months since the last menses] or not surgically sterile [less than 6 months from date of surgery]), she must have a negative urine pregnancy test and must use at least one of the following acceptable contraceptive methods used consistently and correctly during the study (as well as for 4 weeks following the last dose in the study). • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: a. oral b. intravaginal c. transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: a. oral b. injectable c. implantable • intrauterine device (IUD) • intrauterine hormone-releasing system (IUS) • bilateral tubal occlusion • vasectomised partner • sexual abstinence 4. The male partner of the female subject of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery atleast 6 months prior to signing the study ICF and beginning screening), or other contraception deemed adequate by the investigator during the study. a . Male subjects, with a female partner of childbearing potential, should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF), or other contraception deemed adequate by the investigator during the study. 5. Must have a diagnosis of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in both eyes or one eye with POAG and the other with OHT. 6. BCVA of +0.60 logMAR (Snellen equivalent 20/80) or better in each eye. 7. Central corneal thickness = 480 ?m and = 600 ?m in each eye. 8. Anterior chamber angle grade = 2 (Shaffer scale) in each eye. In addition to continuing to meet inclusion criterion 6 (BCVA), the subject must meet the following criteria at Visit 2 (Eligibility, D -2): 9. Completed the required wait/washout period (if required per protocol). 10. At all time points of IOP measurements (08:00, 12:00, and 16:00) at Visit 2 (Eligibility, D -2), have IOP of = 22 mmHg in at least one eye (the same eye), and = 34 mmHg in both eyes. 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Visit 1 (Screening) and Visit 2 (Eligibility, D -2), subjects with any of the following ocular conditions in either eye or with any of the following non-ocular conditions or characteristics are not eligible to participate in the study: General 1. Females who are pregnant, nursing, or planning a pregnancy. 2. Subjects with known or suspected drug or alcohol abuse. 3. Participation in other investigational drugs (oral or topical therapy) or device clinical trials within 28 days prior to Visit 2 (Eligibility, D -2) and/or participation in other investigational drugs (intravitreal injection therapy) within 3 months or 5 half-lives (whichever is longer) prior to Eligibility, Day -2, or planning to participate in other investigational drug or device clinical trials during a time which would overlap with the duration of the study. This includes both ocular and non-ocular clinical trials. Exposure to investigational biologics should be discussed with the medical monitor. Medications / Therapies 4. Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period. 5. Subjects who will be required to initiate or modify any systemic or topical medication known to affect IOP (e.g., ß-adrenergic antagonists, a-adrenergic agonists, calcium channel blockers, angiotensin-converting enzyme [ACE] inhibitors, and angiotensin II receptor blockers [ARBs]). Subjects using the above medications must be on a stable dose use for at least 28 days prior to Visit 2 (Eligibility, D -2) and the duration of the study. 6. Intended or current use of the following prohibited medications/therapies during the study duration: All ocular medications other than sodium chloride/potassium chloride ophthalmic solution, cataract treatment agents (e.g., lutathione, pirenoxine), Vitamin B12 formulation (e.g., cyanocobalamine), over-the-counter artificial tears/drops, and study medications. All systemically administered ocular hypotensive medications (e.g., oral or intravenous CAI, oral glycerol). Any ocular, periocular, inhaled, nasal, or systemic corticosteroids (excluding joint injections). ? Lacrimal/punctal occlusion via plug(s) or cautery. 7. Known allergy, hypersensitivity, or contraindications to prostaglandins, or any other components (e.g., Benzalkonium Chloride [BAK]) of the study medications or other study-related procedures/medications. 8. History of ocular surgery specifically intended to lower IOP (e.g., laser trabeculoplasty, filtering surgery, tube shunt, Minimally Invasive Glaucoma Surgery (MIGS), or trabeculotomy) in either eye. Please note that a history of laser iridotomy is allowed. 9. History of keratorefractive surgery (e.g., radial keratotomy [RK], photorefractivekeratectomy [PRK], laser-assisted-in-situ keratomileusis [LASIK]) in either eye. 10. Use of contact lenses within 1-2 weeks prior to Visit 2 (Eligibility, D -2) until end of treatment in either eye (1 week for soft contact lens wearers, and/or 2 weeks for rigid contact lens wearers). 11. Any ocular surgery within 180 days prior to Visit 2 (Eligibility, D -2) and throughout the study in either eye. Diseases 12. Presence of advanced glaucoma (e.g., visual field mean deviation worse than -12 dB) in either eye. 13. Presence of any corneal abnormality or other conditions interfering with or preventing reliable Goldmann applanation tonometry (e.g., Fuch’s dystrophy or significant corneal surface abnormality) in either eye. 14. Prese
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the 24h IOP lowering characteristics of DE-126 ophthalmic solution 0.002% with latanoprost ophthalmic solution 0.005%, both given once daily in the evening for 3 months+1 day;Secondary Objective: To compare additional characteristics of the 24h IOP efficacy of DE-126 in comparison to latanoprost Safety Objectives To assess the safety profile of DE-126 ophthalmic solution 0.002% given once daily (QD) in subjects with POAG or OHT Exploratory Objectives To explore Quality of Life in subjects with POAG or OHT when given DE-126 or latanoprost for 3 months. To gain experience in self-monitoring of IOP by the subjects;Primary end point(s): Primary Efficacy Endpoint The IOP (mmHg) measured in the study eye (identified at the baseline visit) is the efficacy measure for this study.The IOP at each scheduled time point will be evaluated at each post-baseline visit. Besides observed IOP measurements, change and percent change from baseline in IOP at each scheduled time point as well as the change and percent change from baseline in mean diurnal IOP will also be derived and evaluated.;Timepoint(s) of evaluation of this end point: Mean twenty-four-hour (24h) IOP in the study eye measured at Month 3 at 4h (24:00), 8h (04:00), 12h (08:00), 16h (12:00), 20h (16:00), and 24h (20:00) after the last dose given the previous night at 20:00. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The IOP (mmHg) measured in the study eye (identified at the baseline visit) is the efficacy measure for this study. The IOP at each scheduled time point will be evaluated at each post-baseline visit. Besides observed IOP measurements, change and percent change from baseline in IOP at each scheduled time point as well as the change and percent change from baseline in mean diurnal IOP will also be derived and evaluated.;Timepoint(s) of evaluation of this end point: •Mean 24-h (24h) IOP in the study eye measured at Week 6 at 4h (24:00), 8h (04:00), 12h (08:00), 16h (12:00), 20h (16:00), & 24h (20:00) after last dose given previous night at 20:00 •Mean diurnal (08:00,12:00, 16:00&20:00) & nocturnal (24:00, 04:00) IOP at Week 6 &at Month 3 •IOP at individual time points of 24h IOP curve at Week 6 &Month 3 •Peak and trough IOPs at Week 6&Month 3 •Fluctuation (difference between highest IOP reading minus lowest IOP reading within 24h curve) in IOP at Week 6&Month 3 •Change from baseline for IOP at each time point at Week 6 & Month 3 •IOP measured at 08:00 &12:00 at Week 2 •IOP at 36h (08:00), 42h (14:00) and 48h (20:00) measured at Month 3 +1d after last dose for DE-126 given at Month 3 -1d vs 12h (08:00),18h (14:00) &24h (20:00) for latanoprost | — |
Countries
Austria, Germany, Greece
Contacts
Public ContactResponsible Physician
Santen Oy
Outcome results
None listed