Trial · NCT00578331

Safety Study of Olopatadine Nasal Spray

NCT00578331, Phase 3, Completed, Alcon Research; results first posted 2010-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of Olopatadine Nasal Spray. Trials, record NCT00578331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578331

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Trial

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

Title: Safety Study of Olopatadine Nasal Spray
NCT number: NCT00578331
Status: Completed
Phases: Phase 3
Enrollment: 890 participants, actual
Lead sponsor: Alcon Research
Conditions: Perennial Allergic Rhinitis
Interventions: Olopatadine 0.6% nasal spray, Placebo Nasal Spray
First posted: 2007-12-21
Last updated: 2017-10-31
Results first posted: 2010-02-03

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire	day 30	Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
Secondary	Average Number of Days of Rescue Medication Taken	Month 1 through Month 12

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	Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire	day 30	29 patients had missing mean patient-rated relief assessment data.	Unit on PRRA scale	MEAN
SECONDARY	Average Number of Days of Rescue Medication Taken	Month 1 through Month 12	12 patients had missing average use of rescue medication data.	Days	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire	Placebo Nasal Spray	2.7	Standard Deviation 0.9	Unit on PRRA scale
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire	Olopatadine 0.6% Nasal Spray	2.5	Standard Deviation 0.9	Unit on PRRA scale
Average Number of Days of Rescue Medication Taken	Placebo Nasal Spray	10.2	Standard Deviation 22.4	Days
Average Number of Days of Rescue Medication Taken	Olopatadine 0.6% Nasal Spray	11.8	Standard Deviation 26.6	Days

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Nasal Spray	445
Overall Study	STARTED	Olopatadine 0.6% Nasal Spray	445
Overall Study	COMPLETED	Placebo Nasal Spray	329
Overall Study	COMPLETED	Olopatadine 0.6% Nasal Spray	320
Overall Study	NOT COMPLETED	Placebo Nasal Spray	116
Overall Study	NOT COMPLETED	Olopatadine 0.6% Nasal Spray	125

Source ClinicalTrials.gov

Adverse events82

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	Placebo Nasal Spray	126	445	212
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Olopatadine 0.6% Nasal Spray	111	445	189
other	Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Placebo Nasal Spray	65	445	148
other	Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Olopatadine 0.6% Nasal Spray	46	445	97
other	Headache	Nervous system disorders	Placebo Nasal Spray	56	445	110
other	Headache	Nervous system disorders	Olopatadine 0.6% Nasal Spray	57	445	123
other	Rhinitis	Infections and infestations	Placebo Nasal Spray	73	445	108
other	Rhinitis	Infections and infestations	Olopatadine 0.6% Nasal Spray	87	445	126
other	Upper respiratory tract infection	Infections and infestations	Placebo Nasal Spray	75	445	102
other	Upper respiratory tract infection	Infections and infestations	Olopatadine 0.6% Nasal Spray	73	445	97

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Nasal Spray
Total, all-cause mortality	Olopatadine 0.6% Nasal Spray
Total, other adverse events	Placebo Nasal Spray	319	445
Total, other adverse events	Olopatadine 0.6% Nasal Spray	309	445
Total, serious adverse events	Placebo Nasal Spray	15	445
Total, serious adverse events	Olopatadine 0.6% Nasal Spray	15	445

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 comparisons1

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

Comparison
Olopatadine 0.6% Nasal Spray vs Placebo Nasal Spray: serious adverse events

Source Trial comparisons

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/NCT00578331

GET https://conductscience.org/api/trials/v1/NCT00578331/events?page=2

API reference For AI assistants