Clinical study comparing the efficacy and safety of DE-126with latanoprost in patients with glaucoma (high pressure inside the eye)

Phase 1

Conditions: Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
MedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: LLTClassification code 10036719Term: Primary open angle glaucomaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

Registration Number: EUCTR2020-004836-93-GR

Lead Sponsor: SANTEN INCORPORATED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

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 during the study (as well as for 4 weeks following the last dose in the study).
? Abstinence
? Hormonal contraceptive method (including oral or transdermal contraceptives,
injectable progesterone, progestin subdermal implants, progesterone-releasing
intrauterine devices [IUDs]) initiated at least 28 days prior
? Placement of a copper-containing IUD
? Condom with spermicidal foam/gel/film/cream/suppository
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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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