Trial · NCT00578929

Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

NCT00578929, Phase 3, Completed, Alcon Research; results first posted 2010-02-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients. Trials, record NCT00578929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578929

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Trial

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

Title: Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
NCT number: NCT00578929
Status: Completed
Phases: Phase 3
Enrollment: 2,388 participants, actual
Lead sponsor: Alcon Research
Conditions: Seasonal Allergic Rhinitis
Interventions: Olopatadine Hydrochloride Nasal Spray 0.6%, Vehicle
First posted: 2007-12-21
Last updated: 2010-03-02
Results first posted: 2010-02-09

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)	Baseline through 2 weeks after randomization	Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
Secondary	Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)	Baseline through 2 weeks after randomization	Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)	Baseline through 2 weeks after randomization		Percent change of TNSS from baseline	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)	Baseline through 2 weeks after randomization		Percent change of TOSS from baseline	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)	Olopatadine 0.6% 1 Spray	-25.10	Standard Error 1.45	Percent change of TNSS from baseline
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)	Vehicle 1 Spray	-18.17	Standard Error 1.45	Percent change of TNSS from baseline
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)	Olopatadine 0.6% 2 Sprays	-26.35	Standard Error 1.45	Percent change of TNSS from baseline
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)	Vehicle 2 Sprays	-21.21	Standard Error 1.45	Percent change of TNSS from baseline
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)	Olopatadine 0.6% 1 Spray	-25.02	Standard Error 5.11	Percent change of TOSS from baseline
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)	Vehicle 1 Spray	-6.09	Standard Error 5.10	Percent change of TOSS from baseline
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)	Olopatadine 0.6% 2 Sprays	-25.03	Standard Error 3.33	Percent change of TOSS from baseline
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)	Vehicle 2 Sprays	-9.46	Standard Error 3.37	Percent change of TOSS from baseline

Source ClinicalTrials.gov

Participant flow24

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

Period	Milestone	Group	Participants
Vehicle Run-In Period	STARTED	Olopatadine 0.6% 1 Spray	0
Vehicle Run-In Period	STARTED	Vehicle 1 Spray	2,388
Vehicle Run-In Period	STARTED	Olopatadine 0.6% 2 Sprays	0
Vehicle Run-In Period	STARTED	Vehicle 2 Sprays	0
Vehicle Run-In Period	COMPLETED	Olopatadine 0.6% 1 Spray	0
Vehicle Run-In Period	COMPLETED	Vehicle 1 Spray	2,388
Vehicle Run-In Period	COMPLETED	Olopatadine 0.6% 2 Sprays	0
Vehicle Run-In Period	COMPLETED	Vehicle 2 Sprays	0
Vehicle Run-In Period	NOT COMPLETED	Olopatadine 0.6% 1 Spray	0
Vehicle Run-In Period	NOT COMPLETED	Vehicle 1 Spray	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events15

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	Events
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Olopatadine 0.6% 1 Spray	17	298	18
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Vehicle 1 Spray	11	297	12
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Olopatadine 0.6% 2 Sprays	18	296	19
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Vehicle 2 Sprays	16	297	18
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Vehicle Run-in Period	42	2,388	44
other	Headache	Nervous system disorders	Olopatadine 0.6% 1 Spray	13	298	15
other	Headache	Nervous system disorders	Vehicle 1 Spray	11	297	11
other	Headache	Nervous system disorders	Olopatadine 0.6% 2 Sprays	9	296	9
other	Headache	Nervous system disorders	Vehicle 2 Sprays	16	297	16
other	Headache	Nervous system disorders	Vehicle Run-in Period	68	2,388	68

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Olopatadine 0.6% 1 Spray
Total, all-cause mortality	Vehicle 1 Spray
Total, all-cause mortality	Olopatadine 0.6% 2 Sprays
Total, all-cause mortality	Vehicle 2 Sprays
Total, all-cause mortality	Vehicle Run-in Period
Total, other adverse events	Olopatadine 0.6% 1 Spray	29	298
Total, other adverse events	Vehicle 1 Spray	21	297
Total, other adverse events	Olopatadine 0.6% 2 Sprays	26	296
Total, other adverse events	Vehicle 2 Sprays	30	297
Total, other adverse events	Vehicle Run-in Period	107	2,388

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21477426	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.

GET https://conductscience.org/api/trials/v1/NCT00578929

GET https://conductscience.org/api/trials/v1/NCT00578929/flow?page=2

API reference For AI assistants