Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

• DE-126 Ophthalmic Solution 0.002% QD (Drug): DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
• Timolol Maleate Ophthalmic Solution 0.5% BID (Drug): Timolol Maleate Ophthalmic Solution BID (morning and evening)

Primary outcomes

• Intraocular Pressure at Week 2 [08:00, 10:00 and 16:00 at Week 2]: Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
• Intraocular Pressure at Week 6 [08:00, 10:00 and 16:00 at Week 6]: Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
• Intraocular Pressure at Month 3 [08:00, 10:00 and 16:00 at Month 3]: Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).

Secondary outcomes

• Mean Diurnal Intraocular Pressure at Month 3 [Three months]: Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
* Completed the required wait/washout period
* Qualifying Day 1 IOP measurement at 3 time-points in both eyes

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy
* Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
* History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
* Presence of advanced glaucoma in either eye

Participant flow

Outcome results

• Intraocular Pressure at Week 2 (Primary), Least squares mean, mmHg: Timolol Maleate Opthalmic Solution 0.5% BID 19.05 +/- 0.242; DE-126 Opthalmic Solution 0.002% QD and Vehicle QD 18.92 +/- 0.239
• Intraocular Pressure at Week 6 (Primary), Least squares mean, mmHg: Timolol Maleate Opthalmic Solution 0.5% BID 18.72 +/- 0.238; DE-126 Opthalmic Solution 0.002% QD and Vehicle QD 18.32 +/- 0.233
• Intraocular Pressure at Month 3 (Primary), Least squares mean, mmHg: Timolol Maleate Opthalmic Solution 0.5% BID 18.78 +/- 0.249; DE-126 Opthalmic Solution 0.002% QD and Vehicle QD 18.80 +/- 0.244
• Mean Diurnal Intraocular Pressure at Month 3 (Secondary), Least squares mean, mmHg: Timolol Maleate Opthalmic Solution 0.5% BID 18.43 +/- 0.209; DE-126 Opthalmic Solution 0.002% QD and Vehicle QD 18.15 +/- 0.205

Adverse events

Time frame: From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.

Serious adverse events by term

Other adverse events by term

• Results publication: Wirta DL, El-Harazi SM, Tepedino ME, Bacharach J. Sepetaprost 0.002% Noninferiority vs. Timolol 0.5% in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: ANGEL-2. Ophthalmol Glaucoma. 2025 Jul-Aug;8(4):384-392. doi: 10.1016/j.ogla.2025.02.004. Epub 2025 Mar 4. PMID 40043909

• Study Protocol (PDF, 2021-02-18)
• Statistical Analysis Plan (PDF, 2021-11-15)