Trial · NCT01435460
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
NCT01435460, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2012-03-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC). Trials, record NCT01435460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01435460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
- NCT number
- NCT01435460
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Seasonal Allergic Conjunctivitis
- Interventions
- Loteprednol etabonate 0.2%, Olopatadine 0.1%
- First posted
- 2011-09-16
- Last updated
- 2012-03-13
- Results first posted
- 2012-03-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bulbar Conjunctival Injection | Change from baseline to day 15 (visit 3) | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe |
| Primary | Ocular Itching | Change from baseline to day 15 (visit 3) | Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe |
| Secondary | Bulbar Conjunctival Injection | Change from baseline to day 8 (visit 2) | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe |
| Secondary | Ocular Itching | Change from baseline to day 8 (visit 2) | Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bulbar Conjunctival Injection | Change from baseline to day 15 (visit 3) | Participants analyzed from the per protocol (PP) population | units on a scale | MEAN |
| PRIMARY | Ocular Itching | Change from baseline to day 15 (visit 3) | Participants analyzed from the per protocol (PP) population | units on a scale | MEAN |
| SECONDARY | Bulbar Conjunctival Injection | Change from baseline to day 8 (visit 2) | Participants analyzed from the per protocol (PP) population | units on a scale | MEAN |
| SECONDARY | Ocular Itching | Change from baseline to day 8 (visit 2) | Participants analyzed from the per protocol (PP) population | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bulbar Conjunctival Injection | Alrex | -1.91 | Standard Deviation 0.521 | units on a scale | |
| Bulbar Conjunctival Injection | Patanol | -1.71 | Standard Deviation 0.585 | units on a scale | |
| Ocular Itching | Alrex | -3.74 | Standard Deviation 0.469 | units on a scale | |
| Ocular Itching | Patanol | -3.28 | Standard Deviation 0.908 | units on a scale | |
| Bulbar Conjunctival Injection | Alrex | -1.36 | Standard Deviation 0.569 | units on a scale | |
| Bulbar Conjunctival Injection | Patanol | -1.18 | Standard Deviation 0.610 | units on a scale | |
| Ocular Itching | Alrex | -2.46 | Standard Deviation 0.876 | units on a scale | |
| Ocular Itching | Patanol | -2.02 | Standard Deviation 0.851 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alrex | 151 | |
| Overall Study | STARTED | Patanol | 149 | |
| Overall Study | COMPLETED | Alrex | 140 | |
| Overall Study | COMPLETED | Patanol | 143 | |
| Overall Study | NOT COMPLETED | Alrex | 11 | |
| Overall Study | NOT COMPLETED | Patanol | 6 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Deviated Septum | Respiratory, thoracic and mediastinal disorders | Alrex | 1 | 151 | 1 |
| serious | Deviated Septum | Respiratory, thoracic and mediastinal disorders | Patanol | 0 | 149 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alrex | ||
| Total, all-cause mortality | Patanol | ||
| Total, other adverse events | Alrex | 0 | 151 |
| Total, other adverse events | Patanol | 0 | 149 |
| Total, serious adverse events | Alrex | 1 | 151 |
| Total, serious adverse events | Patanol | 0 | 149 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22627057 | 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 |
|---|
| Alrex vs Patanol: 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/NCT01435460
GET https://conductscience.org/api/trials/v1/NCT01435460/registered