Trial Outcomes & Findings for Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (NCT NCT01240382)

NCT ID: NCT01240382

Last Updated: 2014-08-13

Results Overview

Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 332 participants
• Primary outcome timeframe: Baseline and 4-week (discontinued (LOCF))
• Results posted on: 2014-08-13

Participant Flow

Informed consent was obtained from 332 patients, of whom 287 were randomized and prescribed the study drug.

Participant milestones

Measure	3% DE-089 3% DE-089 ophthalmic solution	0.1% HA 0.1% sodium hyaluronate ophthalmic solution
Overall Study STARTED	144	143
Overall Study COMPLETED	142	139
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	3% DE-089 3% DE-089 ophthalmic solution	0.1% HA 0.1% sodium hyaluronate ophthalmic solution
Overall Study Adverse Event	2	1
Overall Study Lack of Efficacy	0	2
Overall Study Fear of adverse events	0	1

Baseline Characteristics

Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Baseline characteristics by cohort

Measure	3% DE-089 n=144 Participants 3% DE-089 ophthalmic solution	0.1% HA n=143 Participants 0.1% sodium hyaluronate ophthalmic solution	Total n=287 Participants Total of all reporting groups
Age, Continuous	55.3 years STANDARD_DEVIATION 17.1 • n=5 Participants	57.0 years STANDARD_DEVIATION 16.8 • n=7 Participants	56.1 years STANDARD_DEVIATION 16.9 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	125 Participants n=7 Participants	245 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4-week (discontinued (LOCF))

Population: Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining.

Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.

The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.

Outcome measures

Measure	3% DE-089 n=144 Participants 3% DE-089 ophthalmic solution	0.1% HA n=142 Participants 0.1% sodium hyaluronate ophthalmic solution
Mean Change in Fluorescein Staining Score From Baseline	-2.12 points Standard Deviation 1.66	-2.08 points Standard Deviation 1.52

PRIMARY outcome

Timeframe: Baseline and 4-week (discontinued (LOCF))

Population: Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining.

Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better.

The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.

Outcome measures

Measure	3% DE-089 n=144 Participants 3% DE-089 ophthalmic solution	0.1% HA n=141 Participants 0.1% sodium hyaluronate ophthalmic solution
Mean Change in Rose Bengal Staining Score From Baseline	-3.06 points Standard Deviation 2.27	-2.38 points Standard Deviation 2.08

Adverse Events

3% DE-089

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

0.1% HA

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	3% DE-089 n=144 participants at risk 3% DE-089 ophthalmic solution	0.1% HA n=143 participants at risk 0.1% sodium hyaluronate ophthalmic solution
Gastrointestinal disorders Gastrointestinal bleeding	0.00% 0/144	0.70% 1/143

Other adverse events

Measure	3% DE-089 n=144 participants at risk 3% DE-089 ophthalmic solution	0.1% HA n=143 participants at risk 0.1% sodium hyaluronate ophthalmic solution
Eye disorders Eye irritation	6.2% 9/144	0.70% 1/143

Additional Information

General Manager of Clinical Development Group

Santen Pharmaceutical Co., Ltd.

Phone: +81-6-4802-9341

Email: clinical@santen.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place