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CompletedNCT02981446Updated Mar 15, 2024Results posted

A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT

A Phase 3 interventional study of DE-117 and Latanoprost ophthalmic solution in Open Angle Glaucoma or Ocular Hypertension, sponsored by Santen Pharmaceutical Co., Ltd.. Completed at 1 site in Singapore. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Santen Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
370
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.

02

Conditions studied

  • Open Angle Glaucoma or Ocular Hypertension
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with open angle glaucoma or ocular hypertension in both eyes

Exclusion criteria

Exclusion Criteria:

  • Patients at risk of progression of visual field loss
  • Patients with severe visual field defect
  • Patients with any diseases that preclude participation in this study for safety reasons
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
370 participants (actual)

Study arms

  • Experimental
    DE-117 ophthalmic solution

    Drug: DE-117

  • Active comparator
    Latanoprost ophthalmic solution 0.005%

    Drug: Latanoprost ophthalmic solution

Interventions

  • DrugDE-117

    DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.

  • DrugLatanoprost ophthalmic solution

    Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.

    Also known as: Xalatan

05

What researchers measure

Primary outcomes

  1. Mean Diurnal IOP at Month 3

    The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

    Time frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)

Secondary outcomes

  1. IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)

    The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

    Time frame: 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.

  2. Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)

    The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

    Time frame: Week 1

06

Results

Posted Mar 15, 2024

Participant flow

Participant flow — Overall Study
MilestoneDE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%
Started185185
Completed170177
Not completed158

Outcome measures

PrimaryMean Diurnal IOP at Month 3

The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

Time frame:
Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
Reported as:
Least squares mean · mmHg
Mean Diurnal IOP at Month 3
mmHgDE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%
Mean Diurnal IOP at Month 317.5 ± 0.2516.8 ± 0.25
SecondaryIOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)

The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

Time frame:
09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
Reported as:
Least squares mean · mmHg
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)
mmHgDE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%
Week 1 09:0019.0 ± 0.2818.8 ± 0.29
Week 1 13:0018.4 ± 0.2818.4 ± 0.29
Week 1 17:0018.0 ± 0.2818.3 ± 0.28
Week 6 09:0017.8 ± 0.2617.4 ± 0.26
Week 6 13:0017.6 ± 0.2717.2 ± 0.27
Week 6 17:0017.5 ± 0.2617.1 ± 0.27
Month 3 09:0017.9 ± 0.2717.0 ± 0.27
Month 3 13:0017.2 ± 0.2516.7 ± 0.26
Month 3 17:0017.2 ± 0.2616.7 ± 0.27
SecondaryMean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)

The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

Time frame:
Week 1
Reported as:
Least squares mean · mmHg
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)
mmHgDE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)18.5 ± 0.2618.5 ± 0.27

Adverse events

Collected over An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DE-117 Ophthalmic Solution0/185 (0%)2/185 (1.1%)74/185 (40%)
Latanoprost Ophthalmic Solution 0.005%0/185 (0%)2/185 (1.1%)55/185 (29.7%)
Most frequent serious events
Most frequent serious events
EventDE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%
TinnitusEar and labyrinth disorders1/1850/185
Urinary retentionRenal and urinary disorders1/1850/185
Intraductal proliferative breast lesionNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1851/185
Food poisoningGastrointestinal disorders0/1851/185
Most frequent other events
Showing 10 of 79
Most frequent other events
EventDE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%
Conjunctival hyperaemiaEye disorders22/18510/185
PhotophobiaEye disorders10/1851/185
Dry eyeEye disorders9/1854/185
Corneal thickeningEye disorders7/1852/185
Eye painEye disorders5/1856/185
ConjunctivitisInfections and infestations3/1855/185
Ocular hyperaemiaEye disorders4/1854/185
Vision blurredEye disorders4/1852/185
Eye pruritusEye disorders2/1854/185
NasopharyngitisInfections and infestations1/1854/185

Baseline characteristics

All 370 subjects received at least 1 dose of their assigned study medication and were included in the Safety population. Data for all subjects except 1 were included in the Full Analysis Set (FAS); 1 subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.

Age, Categorical
Age, Categorical(Participants)DE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%Total
<=18 years000
Between 18 and 65 years137143280
>=65 years474289
Age, Continuous
Age, Continuous(years)DE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%Total
Mean54.6 ± 12.952.6 ± 13.153.6 ± 13.0
Sex: Female, Male
Sex: Female, Male(Participants)DE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%Total
Female7897175
Male10688194
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)DE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%Total
Hispanic or Latino415
Not Hispanic or Latino166173339
Unknown or Not Reported141125
Race (NIH/OMB)
Race (NIH/OMB)(Participants)DE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%Total
American Indian or Alaska Native000
Asian184185369
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)DE-117 Ophthalmic SolutionLatanoprost Ophthalmic Solution 0.005%Total
India98103201
South Korea212041
Singapore17926
Taiwan4853101
07

Study locations

1 site
  • Singapore, Singapore
08

References and documents

Study documents

  • Study protocol · Jun 28, 2016
  • Statistical analysis plan · Feb 12, 2019

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT02981446
Lead sponsor
Santen Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 5, 2016
Start date
Jan 2017
Primary completion
Jan 2019
Completion
Jan 2019
Results posted
Mar 15, 2024
Last update
Mar 15, 2024

Oversight

Data monitoring committee
No
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