Trial · NCT01817790
Assessment of Fluticasone Propionate on Ocular Allergy Symptoms
NCT01817790, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-04-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assessment of Fluticasone Propionate on Ocular Allergy Symptoms. Trials, record NCT01817790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01817790
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Fluticasone Propionate on Ocular Allergy Symptoms
- NCT number
- NCT01817790
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 626 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Allergic Rhinitis, Seasonal Allergic Rhinitis
- Interventions
- Fluticasone propionate, Placebo
- First posted
- 2013-03-25
- Last updated
- 2014-04-03
- Results first posted
- 2014-04-03
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) | Baseline to 14 days | The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in AM rTOSS | Baseline to 14 days | rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For AM rToss, subjects completed rTOSS in the morning (AM score: prior to nasal spray use). The mean change from baseline in AM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in PM rTOSS | Baseline to 14 days | rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For PM rTOSS, subjects completed rTOSS in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning | Baseline to 14 days | The AM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning | Baseline to 14 days | The PM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering | Baseline to 14 days | The AM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering | Baseline to 14 days | The PM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness | Baseline to 14 days | The AM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness | Baseline to 14 days | The PM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean. |
| Secondary | Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | Baseline to 14 days | Instantaneous total ocular symptom scores (iTOSS) assessments are self perceived evaluation of symptom severity immediately before the dose (how the subject feels at that point in time). iTOSS (possible score of 0-9) is the sum of 3 individual participant-assessed symptom scores for eye itching/burning, eye tearing/watering, and eye redness each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Mean changes from baseline were calculated as treatment period iTOSS minus baseline iTOSS. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in AM rTOSS | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in PM rTOSS | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | Baseline to 14 days | All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. | Score on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) | Fluticasone Propionate Nasal Spray | -0.91 | Standard Deviation 1.625 | Score on a scale | |
| Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) | Placebo Nasal Spray | -0.63 | Standard Deviation 1.525 | Score on a scale | |
| Mean Change From Baseline in AM rTOSS | Fluticasone Propionate Nasal Spray | -0.96 | Standard Deviation 1.627 | Score on a scale | |
| Mean Change From Baseline in AM rTOSS | Placebo Nasal Spray | -0.68 | Standard Deviation 1.573 | Score on a scale | |
| Mean Change From Baseline in PM rTOSS | Fluticasone Propionate Nasal Spray | -0.87 | Standard Deviation 1.735 | Score on a scale | |
| Mean Change From Baseline in PM rTOSS | Placebo Nasal Spray | -0.60 | Standard Deviation 1.577 | Score on a scale | |
| Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning | Fluticasone Propionate Nasal Spray | -0.35 | Standard Deviation 0.581 | Score on a scale | |
| Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning | Placebo Nasal Spray | -0.28 | Standard Deviation 0.553 | Score on a scale | |
| Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning | Fluticasone Propionate Nasal Spray | -0.33 | Standard Deviation 0.626 | Score on a scale | |
| Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning | Placebo Nasal Spray | -0.24 | Standard Deviation 0.554 | Score on a scale |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluticasone Propionate Nasal Spray | 314 | |
| Overall Study | STARTED | Placebo Nasal Spray | 312 | |
| Overall Study | COMPLETED | Fluticasone Propionate Nasal Spray | 310 | |
| Overall Study | COMPLETED | Placebo Nasal Spray | 304 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate Nasal Spray | 4 | |
| Overall Study | NOT COMPLETED | Placebo Nasal Spray | 8 |
Source ClinicalTrials.gov
Adverse events32
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 | Pain | General disorders | Fluticasone Propionate Nasal Spray | 0 | 314 | 0 |
| other | Pain | General disorders | Placebo Nasal Spray | 1 | 312 | 1 |
| other | Pyrexia | General disorders | Fluticasone Propionate Nasal Spray | 1 | 314 | 1 |
| other | Pyrexia | General disorders | Placebo Nasal Spray | 2 | 312 | 2 |
| other | Thirst | General disorders | Fluticasone Propionate Nasal Spray | 1 | 314 | 1 |
| other | Thirst | General disorders | Placebo Nasal Spray | 0 | 312 | 0 |
| other | Bronchitis | Infections and infestations | Fluticasone Propionate Nasal Spray | 0 | 314 | 0 |
| other | Bronchitis | Infections and infestations | Placebo Nasal Spray | 2 | 312 | 2 |
| other | Gastrointestinal Viral | Infections and infestations | Fluticasone Propionate Nasal Spray | 1 | 314 | 1 |
| other | Gastrointestinal Viral | Infections and infestations | Placebo Nasal Spray | 0 | 312 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone Propionate Nasal Spray | ||
| Total, all-cause mortality | Placebo Nasal Spray | ||
| Total, other adverse events | Fluticasone Propionate Nasal Spray | 8 | 314 |
| Total, other adverse events | Placebo Nasal Spray | 8 | 312 |
| Total, serious adverse events | Fluticasone Propionate Nasal Spray | 0 | 314 |
| Total, serious adverse events | Placebo Nasal Spray | 0 | 312 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25624132 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fluticasone Propionate 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.
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/NCT01817790
GET https://conductscience.org/api/trials/v1/NCT01817790/results?page=2