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 (ANGEL-2)

Santen

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: Timolol Maleate Ophthalmic Solution 0.5% BID; Drug: DE-126 Ophthalmic Solution 0.002% QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT04742283

012604IN

Details and patient eligibility

About

Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.

This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

The IOP will be measured at 3 different times throughout the day, over 4 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, and vital signs. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

Enrollment: 323 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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323 participants in 2 patient groups

DE-126 Opthalmic Solution 0.002% QD and Vehicle QD

Experimental group

Description:

DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)

Treatment:

Drug: DE-126 Ophthalmic Solution 0.002% QD

Timolol Maleate Opthalmic Solution 0.5% BID

Active Comparator group

Description:

Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)

Treatment:

Drug: Timolol Maleate Ophthalmic Solution 0.5% BID