Trial · NCT01010282

Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

NCT01010282, Not applicable, Completed, Allergan; results first posted 2011-12-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects. Trials, record NCT01010282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01010282

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Trial

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

Title: Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
NCT number: NCT01010282
Status: Completed
Phases: Not applicable
Enrollment: 288 participants, actual
Lead sponsor: Allergan
Conditions: Dry Eye Syndrome
Interventions: Glycerin and Polysorbate 80 based artificial tear, Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear, Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
First posted: 2009-11-10
Last updated: 2015-08-17
Results first posted: 2011-12-13

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Baseline (Day 1), Day 90	Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.
Secondary	Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90	Baseline (Day 1), Day 90	Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Secondary	Change From Baseline in Tear Break-up Time (TBUT) at Day 90	Baseline (Day 1), Day 90	Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).
Secondary	Change From Baseline in Corneal Staining at Day 90	Baseline (Day 1), Day 90	Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).
Secondary	Change From Baseline in Conjunctival Staining Severity Score at Day 90	Baseline (Day 1), Day 90	Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Baseline (Day 1), Day 90	Intent-to-treat, which includes all patients who started the study (randomized).	Scores on a Scale	MEAN
SECONDARY	Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90	Baseline (Day 1), Day 90	Intent-to-treat, which includes all patients who started the study (randomized).	Scores on a Scale	MEAN
SECONDARY	Change From Baseline in Tear Break-up Time (TBUT) at Day 90	Baseline (Day 1), Day 90	Intent-to-treat, which includes all patients who started the study (randomized).	Seconds	MEAN
SECONDARY	Change From Baseline in Corneal Staining at Day 90	Baseline (Day 1), Day 90	Intent-to-treat, which includes all patients who started the study (randomized).	Scores on a scale	MEAN
SECONDARY	Change From Baseline in Conjunctival Staining Severity Score at Day 90	Baseline (Day 1), Day 90	Intent-to-treat, which includes all patients who started the study (randomized).	Scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Artificial Tears Formulation 1	Baseline (Day 1)	2.7	Standard Deviation 0.59	Scores on a Scale
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Artificial Tears Formulation 2	Baseline (Day 1)	2.8	Standard Deviation 0.67	Scores on a Scale
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Glycerin and Polysorbate 80 Based Artificial Tear	Baseline (Day 1)	2.8	Standard Deviation 0.65	Scores on a Scale
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Artificial Tears Formulation 1	Change from Baseline at Day 90	-0.7	Standard Deviation 0.89	Scores on a Scale
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Artificial Tears Formulation 2	Change from Baseline at Day 90	-0.7	Standard Deviation 0.90	Scores on a Scale
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Glycerin and Polysorbate 80 Based Artificial Tear	Change from Baseline at Day 90	-0.7	Standard Deviation 0.96	Scores on a Scale
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90	Artificial Tears Formulation 1	Baseline (Day 1)	33.6	Standard Deviation 20.19	Scores on a Scale
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90	Artificial Tears Formulation 2	Baseline (Day 1)	35.1	Standard Deviation 19.18	Scores on a Scale
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90	Glycerin and Polysorbate 80 Based Artificial Tear	Baseline (Day 1)	37.3	Standard Deviation 18.67	Scores on a Scale
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90	Artificial Tears Formulation 1	Change from Baseline at Day 90	-7.2	Standard Deviation 19.47	Scores on a Scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Artificial Tears Formulation 1	97
Overall Study	STARTED	Artificial Tears Formulation 2	95
Overall Study	STARTED	Glycerin and Polysorbate 80 Based Artificial Tear	96
Overall Study	COMPLETED	Artificial Tears Formulation 1	91
Overall Study	COMPLETED	Artificial Tears Formulation 2	88
Overall Study	COMPLETED	Glycerin and Polysorbate 80 Based Artificial Tear	77
Overall Study	NOT COMPLETED	Artificial Tears Formulation 1	6
Overall Study	NOT COMPLETED	Artificial Tears Formulation 2	7
Overall Study	NOT COMPLETED	Glycerin and Polysorbate 80 Based Artificial Tear	19

Source ClinicalTrials.gov

Adverse events33

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	Visual acuity reduced	Eye disorders	Artificial Tears Formulation 1	16	97
other	Visual acuity reduced	Eye disorders	Artificial Tears Formulation 2	7	95
other	Visual acuity reduced	Eye disorders	Glycerin and Polysorbate 80 Based Artificial Tear	11	96
other	Vision blurred	Eye disorders	Artificial Tears Formulation 1	5	97
other	Vision blurred	Eye disorders	Artificial Tears Formulation 2	3	95
other	Vision blurred	Eye disorders	Glycerin and Polysorbate 80 Based Artificial Tear	7	96
other	Eye pain	Eye disorders	Artificial Tears Formulation 1	3	97
other	Eye pain	Eye disorders	Artificial Tears Formulation 2	1	95
other	Eye pain	Eye disorders	Glycerin and Polysorbate 80 Based Artificial Tear	6	96
other	Photophobia	Eye disorders	Artificial Tears Formulation 1	3	97

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Artificial Tears Formulation 1
Total, all-cause mortality	Artificial Tears Formulation 2
Total, all-cause mortality	Glycerin and Polysorbate 80 Based Artificial Tear
Total, other adverse events	Artificial Tears Formulation 1	28	97
Total, other adverse events	Artificial Tears Formulation 2	14	95
Total, other adverse events	Glycerin and Polysorbate 80 Based Artificial Tear	37	96
Total, serious adverse events	Artificial Tears Formulation 1	2	97
Total, serious adverse events	Artificial Tears Formulation 2	0	95
Total, serious adverse events	Glycerin and Polysorbate 80 Based Artificial Tear	4	96

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25659956	DERIVED

Source PubMed

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.

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