Trial Outcomes & Findings for DE-117 Spectrum 5 Study (NCT NCT03697811)
NCT ID: NCT03697811
Last Updated: 2023-08-30
Results Overview
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
Month 3
Results posted on
2023-08-30
Participant Flow
Participant milestones
| Measure |
DE-117 Ophthalmic Solution 0.002%
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DE-117 Spectrum 5 Study
Baseline characteristics by cohort
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Full Analysis Set (observed cases only)
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=102 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
|
-2.96 mmHg
Standard Deviation 2.831
|
SECONDARY outcome
Timeframe: week 2, 6 and month 3Population: Full Analysis Set (observed cases only).
The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
Week 2
|
-12.21 Percent change
Standard Deviation 10.855
|
|
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
Week 6
|
-12.40 Percent change
Standard Deviation 11.218
|
|
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
Month 3
|
-12.57 Percent change
Standard Deviation 11.907
|
SECONDARY outcome
Timeframe: week 2 and 6Population: Full Analysis Set (observed cases only).
Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
Week 6
|
-2.89 mmHg
Standard Deviation 2.578
|
|
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
Week 2
|
-2.87 mmHg
Standard Deviation 2.531
|
SECONDARY outcome
Timeframe: 08:00, 12:00 and 16:00 at Week 2Population: Full Analysis Set (observed cases only).
Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Change From Baseline in IOP at Timepoints at Week 2
8:00
|
-2.52 mmHg
Standard Deviation 2.976
|
|
Change From Baseline in IOP at Timepoints at Week 2
12:00
|
-2.94 mmHg
Standard Deviation 2.922
|
|
Change From Baseline in IOP at Timepoints at Week 2
16:00
|
-3.15 mmHg
Standard Deviation 3.077
|
SECONDARY outcome
Timeframe: 08:00, 12:00 and 16:00 at Week 6Population: Full Analysis Set (observed cases only)
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Change From Baseline in IOP at Timepoints at Week 6
8:00
|
-2.42 mmHg
Standard Deviation 3.209
|
|
Change From Baseline in IOP at Timepoints at Week 6
12:00
|
-2.86 mmHg
Standard Deviation 2.832
|
|
Change From Baseline in IOP at Timepoints at Week 6
16:00
|
-3.44 mmHg
Standard Deviation 3.127
|
SECONDARY outcome
Timeframe: 08:00, 12:00 and 16:00 at month 3Population: Full Analysis Set (observed cases only).
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Change From Baseline in IOP at Timepoints at Month 3
8:00
|
-2.76 mmHg
Standard Deviation 3.180
|
|
Change From Baseline in IOP at Timepoints at Month 3
12:00
|
-2.98 mmHg
Standard Deviation 3.200
|
|
Change From Baseline in IOP at Timepoints at Month 3
16:00
|
-3.08 mmHg
Standard Deviation 3.186
|
SECONDARY outcome
Timeframe: 08:00, 12:00 and 16:00 at week 2Population: Full Analysis Set (observed cases only).
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
8:00
|
-10.42 Percent change
Standard Deviation 12.509
|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
12:00
|
-12.51 Percent change
Standard Deviation 12.765
|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
16:00
|
-13.47 Percent change
Standard Deviation 13.204
|
SECONDARY outcome
Timeframe: 08:00, 12:00 and 16:00 at week 6Population: Full Analysis Set
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
8:00
|
-10.04 Percent change
Standard Deviation 13.653
|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
12:00
|
-12.22 Percent change
Standard Deviation 12.432
|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
16:00
|
-14.80 Percent change
Standard Deviation 13.482
|
SECONDARY outcome
Timeframe: 08:00, 12:00 and 16:00 at month 3.Population: Full Analysis Set (observed cases only).
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Outcome measures
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 Participants
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
|
|---|---|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
8:00
|
-11.43 Percent change
Standard Deviation 13.133
|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
12:00
|
-12.72 Percent change
Standard Deviation 13.467
|
|
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
16:00
|
-13.13 Percent change
Standard Deviation 13.309
|
Adverse Events
DE-117 Ophthalmic Solution 0.002%
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DE-117 Ophthalmic Solution 0.002%
n=107 participants at risk
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
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|---|---|
|
Eye disorders
Eye pain
|
1.9%
2/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
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Eye disorders
Anterior chamber cell
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Eye disorders
Conjunctival oedema
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Eye disorders
Eye irritation
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Eye disorders
Eyelash hyperpigmentation
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Eye disorders
Macular oedema
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Eye disorders
Photophobia
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Eye disorders
Vision blurred
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
General disorders
Instillation site foreign body sensation
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
General disorders
Instillation site pain
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Investigations
Vital dye staining cornea present
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Infections and infestations
Bronchitis
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Infections and infestations
Influenza
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
General disorders
Cyst
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Nervous system disorders
Dizziness
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Nervous system disorders
Headache
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Psychiatric disorders
Depression
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Vascular disorders
Hypertension
|
0.93%
1/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Eye disorders
Conjunctival hyperaemia
|
8.4%
9/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
|
Eye disorders
Punctate keratitis
|
2.8%
3/107 • Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication. AEs were followed to resolution and until the subject's exit from the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place