Trial Outcomes & Findings for A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis (NCT NCT01363713)

Results Overview

Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

130 participants

Primary outcome timeframe

From baseline to 8-week

Results posted on

2014-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	DE-114 Ophthalmic Solution DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
Overall Study STARTED	130
Overall Study ALLOCATED	130
Overall Study COMPLETED	124
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	DE-114 Ophthalmic Solution DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
Overall Study Adverse Event	1
Overall Study Protocol Violation	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DE-114 Ophthalmic Solution n=130 Participants DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
Age, Continuous	40.2 years STANDARD_DEVIATION 13.0 • n=39 Participants
Sex: Female, Male Female	69 Participants n=39 Participants
Sex: Female, Male Male	61 Participants n=39 Participants

PRIMARY outcome

Timeframe: From baseline to 8-week

Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.

Outcome measures

Outcome measures
Measure	DE-114 Ophthalmic Solution n=130 Participants DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
Change in Ocular Itching Score by Visit Change in baseline to visit 2 (Day7)	-0.6 score Standard Error 0.1
Change in Ocular Itching Score by Visit Change in baseline to visit 3 (Day14)	-0.9 score Standard Error 0.1
Change in Ocular Itching Score by Visit Change in baseline to visit 4 (Day28)	-1.3 score Standard Error 0.1
Change in Ocular Itching Score by Visit Change in baseline to visit 5 (Day42)	-1.7 score Standard Error 0.1
Change in Ocular Itching Score by Visit Change in baseline to visit 6 (Day56)	-2.2 score Standard Error 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 8-week

Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.

Outcome measures

Outcome measures
Measure	DE-114 Ophthalmic Solution n=130 Participants DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
Change in Palpebral Hyperemia Score by Visit Change in baseline to visit 2 (Day7)	-0.3 score Standard Error 0.0
Change in Palpebral Hyperemia Score by Visit Change in baseline to visit 3 (Day14)	-0.3 score Standard Error 0.1
Change in Palpebral Hyperemia Score by Visit Change in baseline to visit 4 (Day28)	-0.6 score Standard Error 0.1
Change in Palpebral Hyperemia Score by Visit Change in baseline to visit 5 (Day42)	-0.7 score Standard Error 0.1
Change in Palpebral Hyperemia Score by Visit Change in baseline to visit 6 (Day56)	-1.0 score Standard Error 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 8-week

Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.

Outcome measures

Outcome measures
Measure	DE-114 Ophthalmic Solution n=130 Participants DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
Change in Bulbar Conjunctiva Hyperemia Score by Visit Change in baseline to visit 2 (Day7)	-0.4 score Standard Error 0.1
Change in Bulbar Conjunctiva Hyperemia Score by Visit Change in baseline to visit 3 (Day14)	-0.4 score Standard Error 0.1
Change in Bulbar Conjunctiva Hyperemia Score by Visit Change in baseline to visit 4 (Day28)	-0.6 score Standard Error 0.1
Change in Bulbar Conjunctiva Hyperemia Score by Visit Change in baseline to visit 5 (Day42)	-0.7 score Standard Error 0.1
Change in Bulbar Conjunctiva Hyperemia Score by Visit Change in baseline to visit 6 (Day56)	-0.8 score Standard Error 0.1

Adverse Events

DE-114 Ophthalmic Solution

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DE-114 Ophthalmic Solution n=130 participants at risk DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
Infections and infestations Nasopharyngitis	6.9% 9/130 • 8-week

Additional Information

General Manager of Clinical Development Group

Santen Pharmaceutical Co., Ltd.

Phone: +81-6-4802-9341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place