Trial · NCT01189032

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

NCT01189032, Phase 2, Completed, Santen Pharmaceutical Co., Ltd.; results first posted 2014-08-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye. Trials, record NCT01189032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01189032

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
NCT number: NCT01189032
Status: Completed
Phases: Phase 2
Enrollment: 320 participants, actual
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Conditions: Dry Eye
Interventions: DE-089 ophthalmic solution, DE-089 ophthalmic solution, Placebo ophthalmic solution
First posted: 2010-08-26
Last updated: 2014-08-13
Results first posted: 2014-08-08

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change in Fluorescein Staining Score From Baseline	Baseline and 4-week (discontinued(LOCF))	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change in Fluorescein Staining Score From Baseline	Baseline and 4-week (discontinued(LOCF))	Efficacy analysis was performed per protocol set (PPS). Excluded cases were 7 subjects (3 subjects in 3% group, 3 subjects in 1% group, and 1 subject in Placebo group).~The reason of exclusion: used the prohibited concomitant drug, dosing period shortage, number of doses non-compliance, or had no available efficacy data.	points	MEAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Change in Fluorescein Staining Score From Baseline	Placebo	-0.95	Standard Deviation 1.33	points
Mean Change in Fluorescein Staining Score From Baseline	Low Concentration	-1.34	Standard Deviation 1.43	points
Mean Change in Fluorescein Staining Score From Baseline	High Concentration	-1.55	Standard Deviation 1.30	points

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	94
Overall Study	STARTED	Low Concentration	96
Overall Study	STARTED	High Concentration	96
Overall Study	COMPLETED	Placebo	89
Overall Study	COMPLETED	Low Concentration	89
Overall Study	COMPLETED	High Concentration	90
Overall Study	NOT COMPLETED	Placebo	5
Overall Study	NOT COMPLETED	Low Concentration	7
Overall Study	NOT COMPLETED	High Concentration	6

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Eye irritation	Eye disorders	Placebo	3	94
other	Eye irritation	Eye disorders	Low Concentration	7	96
other	Eye irritation	Eye disorders	High Concentration	13	96
other	Eye pain	Eye disorders	Placebo	4	94
other	Eye pain	Eye disorders	Low Concentration	2	96
other	Eye pain	Eye disorders	High Concentration	6	96
other	Nasopharyngitis	Infections and infestations	Placebo	10	94
other	Nasopharyngitis	Infections and infestations	Low Concentration	5	96
other	Nasopharyngitis	Infections and infestations	High Concentration	9	96
serious	Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Placebo	0	94

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Low Concentration
Total, all-cause mortality	High Concentration
Total, other adverse events	Placebo	17	94
Total, other adverse events	Low Concentration	14	96
Total, other adverse events	High Concentration	28	96
Total, serious adverse events	Placebo	0	94
Total, serious adverse events	Low Concentration	0	96
Total, serious adverse events	High Concentration	1	96

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01189032

GET https://conductscience.org/api/trials/v1/NCT01189032/registered

API reference For AI assistants