Open Angle Glaucoma or Ocular Hypertension

Primary Objective: To determine if the mean diurnal intraocular pressure (IOP) reduction with DE-117 ophthalmic solution 0.002% is non-inferior to Latanoprost ophthalmic solution 0.005% at Month 3 in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

DE-117

DE-117

ophthalmic solution

0.002%

Primary Efficacy Endpoint:
 Mean diurnal IOP (average of IOP at three time points: 9:00, 13:00 and 17:00) in the study eye at Visit 5 (Month 3).

At Visit 1 (Screening) and Visit 2 (Baseline, Day 1), the subject must meet all of the following
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 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 surgically sterile [less than 6 months]), she must have a
negative urine pregnancy test and must use at least one of the following acceptable
contraceptive methods during the study.
 Abstinence
 Hormonal contraceptive method- oral and 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
 Vasectomized male partner (surgery at least 6 months prior)
4. Subjects must have a diagnosis of OAG (Primary Open Angle Glaucoma [POAG],
Pigmentary Glaucoma, or Pseudoexfoliative Glaucoma) or OHT in both eyes.
5. Corrected visual acuity of +0.60 logMAR (Snellen equivalent 20/80) or better in each eye.
6. Central corneal thickness ≥ 480 m and ≤ 600 m in each eye.
7. Anterior chamber angle grade ≥ 2 (Shaffer scale) in each eye.
In addition, the subject must meet the following criteria at Visit 2 (Baseline, Day 1):
8. Completed the required wait/wash-out period.
9. At all time points of IOP measurements (9:00, 13:00 and 17:00), have IOP of ≥ 22 mmHg in either eye and ≤ 34 mmHg in both eyes.

At Visit 1 (Screening) and Visit 2 (Baseline, Day 1), a subject with any of the following ocular
conditions in any eye or non-ocular conditions or characteristics are not eligible to participate in the study:
General1. Females who are pregnant, nursing or planning a pregnancy.
2. Subjects with known or suspected drug or alcohol abuse.
3. Current or planned participation in any other clinical trial involving an investigational
product or device within 4 weeks prior to Visit 1 (Screening) or at any time during this trial.
4. Subjects who have been exposed to DE-117 prior to Visit 1 (Screening).
Medications / Therapies5. Intended or current use of the following prohibited medications during the study:
 All ocular medications other than sodium chloride/potassium chloride
ophthalmic solution, cataract treatment agents (e.g., glutathione, pirenoxine),
Vitamin B12 formulation (e.g., cyanocobalamine) and study medications.
 All systemic medications for ocular hypotensive (e.g., oral or intravenous CAI, oral glycerol).
 Any ocular, periocular, inhaled, nasal or systemic corticosteroids.
6. Subjects who cannot safely discontinue use of ocular hypotensive medications during
the wait/wash-out period.
7. Subjects who will be required to initiate or modify any systemic or topical medication
known to affect IOP (e.g., β-adrenergic antagonists, α-adrenergic agonists, calcium
channel blockers, angiotensin-converting enzyme [ACE] inhibitors, and angiotensin II receptor blockers [ARB]).
8. Use of contact lenses within one week prior to Visit 2 (Baseline, Day 1) until end of treatment in either eye.
9. Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening)
and throughout the study in either eye.
10. History of ocular surgery specifically intended to lower IOP (e.g. laser trabeculoplasty,
filtering surgery, Minimally Invasive Glaucoma Surgery (MIGS), or trabeculotomy) in either eye.
11. History of keratorefractive surgery in either eye.
12. Allergy, hypersensitivity or contraindications to prostaglandins, benzalkonium chloride
(BAK) or any other components of the study medications, or other study related procedures/medications.
Diseases13. Presence of advanced glaucoma (e.g., visual field mean deviation worse than -12 dB) in either eye.
14. Presence of any corneal abnormality or other condition interfering with or preventing
reliable Goldmann applanation tonometry (e.g. Fuch’s dystrophy or significant corneal
surface abnormality) in either eye.
15. Presence of any active severe external ocular disease, inflammation, or infection of the
eye and/or eyelids in either eye.
16. Presence of clinically significant macular edema in either eye.
17. History of severe ocular trauma in either eye.
18. History of iritis and/or uveitis in either eye.
19. History of retinal detachment, proliferative diabetic retinopathy, or any retinal disease
that may be progressive during the time course of the study in either eye.
20. Presence or history of any disease or condition that in the opinion of the study
investigator may put the subject at significant risk, may confound study results, or may
interfere significantly with the subject’s participation in the study (e.g., recurrent
corneal erosion syndrome, uncontrolled cardiovascular disease etc.).
21. Any decision by the Investigator or Medical Monitor to terminate a subject in screening
or declare any subject ineligible for any sound medical reason.