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NCT Number: NCT04742283

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

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Eye Center, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Intraocular Pressure at Week 2

    Time frame: 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).

  2. Intraocular Pressure at Week 6

    Time frame: 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).

  3. Intraocular Pressure at Month 3

    Time frame: 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

  1. Mean Diurnal Intraocular Pressure at Month 3

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study title

A Phase IIb, Randomized, Double-Masked, Active-Controlled, Parallel-Group, 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

Acronym: ANGEL-2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2021
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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