Trial Outcomes & Findings for A Phase III Multinational Multicenter Investigator-Masked Randomized Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT04133311)

Last Updated: 2024-05-28

Results Overview

Intraocular Pressure (IOP) change from baseline peak (mmHg). IOP was measured using calibrated Goldman applanation tonometer in the morning (9:00 am ± 1 hour). Analysis using Mixed-Effects Model for Repeated Measures (MMRM).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

386 participants

Primary outcome timeframe

Week 12 (09:00) peak timepoint

Results posted on

2024-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	DE-130A DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Xalatan® Xalatan®: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	DE-130A/DE-130A DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants continued to use DE-130A for additional 12 months. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.	Xalatan®/DE-130A DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants were converted to use DE-130A instead of Xalatan®. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.
Period 1 Double Masked Treatment Period STARTED	193	193	0	0
Period 1 Double Masked Treatment Period COMPLETED	190	190	0	0
Period 1 Double Masked Treatment Period NOT COMPLETED	3	3	0	0
Period 2 Open Label Treatment Period STARTED	0	0	71	66
Period 2 Open Label Treatment Period COMPLETED	0	0	67	62
Period 2 Open Label Treatment Period NOT COMPLETED	0	0	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	DE-130A DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Xalatan® Xalatan®: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	DE-130A/DE-130A DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants continued to use DE-130A for additional 12 months. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.	Xalatan®/DE-130A DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants were converted to use DE-130A instead of Xalatan®. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.
Period 1 Double Masked Treatment Period Death	1	0	0	0
Period 1 Double Masked Treatment Period Adverse Event	1	1	0	0
Period 1 Double Masked Treatment Period Withdrawal by Subject	1	1	0	0
Period 1 Double Masked Treatment Period Sponsor Temporarily Discontinued Study	0	1	0	0
Period 2 Open Label Treatment Period Adverse Event	0	0	0	2
Period 2 Open Label Treatment Period Withdrawal by Subject	0	0	2	2
Period 2 Open Label Treatment Period Pregnancy	0	0	1	0
Period 2 Open Label Treatment Period Early Termination	0	0	1	0

Baseline Characteristics

Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DE-130A n=193 Participants DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Xalatan® n=193 Participants Xalatan®: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Total n=386 Participants Total of all reporting groups
Age, Categorical Double Masked Period · <=18 years	0 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.	0 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.	0 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.
Age, Categorical Double Masked Period · Between 18 and 65 years	102 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.	94 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.	196 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.
Age, Categorical Double Masked Period · >=65 years	90 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.	98 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.	188 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days). Overall total number of baseline participants in the Double Masked Treatment Period are 384 subjects.
Age, Continuous Double Masked Period	62.3 years STANDARD_DEVIATION 12.07 • n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	63.9 years STANDARD_DEVIATION 10.14 • n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	63.1 years STANDARD_DEVIATION 11.16 • n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Sex: Female, Male Double Masked Period · Female	120 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	116 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	236 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Sex: Female, Male Double Masked Period · Male	72 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	76 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	148 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Race (NIH/OMB) Double Masked Period · American Indian or Alaska Native	0 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	0 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	0 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Race (NIH/OMB) Double Masked Period · Asian	4 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	4 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	8 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Race (NIH/OMB) Double Masked Period · Native Hawaiian or Other Pacific Islander	2 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	2 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	4 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Race (NIH/OMB) Double Masked Period · Black or African American	0 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	0 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	0 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Race (NIH/OMB) Double Masked Period · White	184 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	186 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	370 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Race (NIH/OMB) Double Masked Period · More than one race	1 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	0 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	1 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Race (NIH/OMB) Double Masked Period · Unknown or Not Reported	1 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	0 Participants n=192 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).	1 Participants n=384 Participants • Measure Analysis Population Description: Double Masked Period: 3-month treatment period, DE-130A vs Xalatan®: Randomization/baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days).
Region of Enrollment Austria	5 participants n=193 Participants	2 participants n=193 Participants	7 participants n=386 Participants
Region of Enrollment Belgium	5 participants n=193 Participants	6 participants n=193 Participants	11 participants n=386 Participants
Region of Enrollment Estonia	13 participants n=193 Participants	16 participants n=193 Participants	29 participants n=386 Participants
Region of Enrollment Finland	3 participants n=193 Participants	2 participants n=193 Participants	5 participants n=386 Participants
Region of Enrollment France	4 participants n=193 Participants	0 participants n=193 Participants	4 participants n=386 Participants
Region of Enrollment Germany	7 participants n=193 Participants	8 participants n=193 Participants	15 participants n=386 Participants
Region of Enrollment Italy	19 participants n=193 Participants	18 participants n=193 Participants	37 participants n=386 Participants
Region of Enrollment Latvia	14 participants n=193 Participants	12 participants n=193 Participants	26 participants n=386 Participants
Region of Enrollment Poland	4 participants n=193 Participants	5 participants n=193 Participants	9 participants n=386 Participants
Region of Enrollment Spain	19 participants n=193 Participants	24 participants n=193 Participants	43 participants n=386 Participants
Region of Enrollment United Kingdom	8 participants n=193 Participants	5 participants n=193 Participants	13 participants n=386 Participants
Region of Enrollment Russia	89 participants n=193 Participants	92 participants n=193 Participants	181 participants n=386 Participants
Region of Enrollment South Korea	3 participants n=193 Participants	3 participants n=193 Participants	6 participants n=386 Participants

PRIMARY outcome

Timeframe: Week 12 (09:00) peak timepoint

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of the study medication and provided at least one post-baseline IOP measurement at peak and trough timepoints separately. The number analyzed are participants evaluable for the outcome measure at Week 12 (09:00) timepoint.

Outcome measures

Outcome measures
Measure	DE-130A n=188 Participants DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Xalatan® n=189 Participants Xalatan®: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT
Intraocular Pressure (IOP) Change (mmHg) at Week 12	-8.8 mmHg Standard Error 0.25	-8.2 mmHg Standard Error 0.26

PRIMARY outcome

Timeframe: Week 12 (16:00) trough timepoint

Intraocular Pressure (IOP) change from baseline trough (mmHg). IOP was measured using calibrated Goldman applanation tonometer in the afternoon (4:00 pm ± 1 hour). Analysis using Mixed-Effects Model for Repeated Measures (MMRM).

Outcome measures

Outcome measures
Measure	DE-130A n=186 Participants DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Xalatan® n=188 Participants Xalatan®: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT
Intraocular Pressure (IOP) Change (mmHg) at Week 12	-8.6 mmHg Standard Error 0.24	-8.1 mmHg Standard Error 0.25

SECONDARY outcome

Timeframe: Week 12

Population: The number analyzed are participants evaluable for the outcome measure at Week 12 with CFS change from baseline in participants with baseline CFS score ≥ 1. Data were obtained by fitting a Mixed-Effects Model for Repeated Measures (MMRM) to the CFS change from baseline at each visit.

CFS Change from baseline in participants with baseline CFS score ≥ 1 at Week 12 Staining using fluorescein were graded using the Modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 per area for cornea and conjunctiva separately) as shown below: * Score = 0: No staining dots * Score = 0.5: One staining dot per area * Score = 1: More staining dot per area than score 0.5 * Score = 2: More staining dot per area than score 1 * Score = 3: More staining dot per area than score 2 * Score = 4: More staining dot per area than score 3 * Score = 5: More staining dot per area than score 4 A Mixed-Effects Model for Repeated Measures (MMRM) was fitted to the CFS change from baseline at each visit.

Outcome measures

Outcome measures
Measure	DE-130A n=80 Participants DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Xalatan® n=86 Participants Xalatan®: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT
Corneal Fluorescein Staining (CFS) Change From Baseline (First Key Secondary Endpoint)	-0.71 score Standard Error 0.069	-0.41 score Standard Error 0.077

SECONDARY outcome

Timeframe: Week 12

Population: The number analyzed are participants evaluable for the outcome measure at Week 12 with change from baseline in OSD symptom score\>0 (average of 3 symptoms).

Change from baseline in OSD symptom score (average of 3 symptoms: dry eye sensation, blurred/poor vision and burning/stinging/itching) in the study eye at Week 12 in patients with baseline symptom average score\>0. Ocular symptoms were graded on a 5-point scale as shown below: * Scale = 0: Absent * Scale = 1: Mild * Scale = 2: Moderate * Scale = 3: Severe * Scale = 4: Very severe Least Square Means and p-values were obtained by fitting a Mixed-Effects Model for Repeated Measures (MMRM) model to the Ocular Surface Disease (OSD) average change from baseline at each visit.

Outcome measures

Outcome measures
Measure	DE-130A n=99 Participants DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Xalatan® n=104 Participants Xalatan®: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT
Ocular Surface Disease (OSD) Symptoms (Average of 3 Symptoms); Second Key Secondary Endpoint	-0.26 score Standard Error 0.058	-0.17 score Standard Error 0.060

Adverse Events

DE-130A

Serious events: 1 serious events

Other events: 35 other events

Deaths: 1 deaths

Xalatan®

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

DE-130A/DE-130A

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Xalatan®/DE-130A

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DE-130A n=193 participants at risk DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	Xalatan® n=193 participants at risk Xalatan®: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT	DE-130A/DE-130A n=71 participants at risk DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants continued to use DE-130A for additional 12 months. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.	Xalatan®/DE-130A n=66 participants at risk DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants were converted to use DE-130A instead of Xalatan®. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.
Cardiac disorders Acute Heart Failure	0.52% 1/193 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.00% 0/193 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.00% 0/71 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.00% 0/66 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.
Respiratory, thoracic and mediastinal disorders Bilateral Pulmonary Thrombosis	0.00% 0/193 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.52% 1/193 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.00% 0/71 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.00% 0/66 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Patient Diagnosed With Bladder Cancer	0.00% 0/193 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.52% 1/193 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.00% 0/71 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.	0.00% 0/66 • Period 1: 3-month from Randomization/baseline visit (Day 1), to Week 12 (±3 days). Period 2: 12-month follow-up from Week 12, from Week 12(±3 days) to Month 15 (± 1 week) visits. Adverse Events were collected from time of informed consent and were followed to resolution or until subject's participation in the study ended. Other Adverse Event data is a summary observed at a rate of 0% by System Organ Class and Preferred Term for both the Double Masked and Open Label Periods.

Other adverse events

Additional Information

Director of R&D Quality Management

Santen Inc

Phone: 15106851794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place