Trial · NCT01479374
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
NCT01479374, Phase 3, Completed, Alcon Research; results first posted 2013-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model. Trials, record NCT01479374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01479374
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
- NCT number
- NCT01479374
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 397 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Allergic Conjunctivitis
- Interventions
- AL-4943A ophthalmic solution, AL-4943A vehicle, Olopatadine hydrochloride ophthalmic solution, 0.2%
- First posted
- 2011-11-24
- Last updated
- 2013-06-04
- Results first posted
- 2013-05-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Ocular Itching at Onset of Action | 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment | A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed. |
| Primary | Mean Ocular Itching at 16 Hours Duration of Action | 3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment | A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed. |
| Secondary | Mean Conjunctival Redness at Onset of Action | 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment | A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. |
| Secondary | Mean Conjunctival Redness at 16 Hours Duration of Action | 7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment | A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. |
| Secondary | Mean Total Redness at 24 Hours Duration of Action | 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment | A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed. |
| Secondary | Mean Ocular Itching at 24 Hours Duration of Action | 3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment | A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed. |
| Secondary | Mean Conjunctival Redness at 24 Hours Duration of Action | 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment | A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Ocular Itching at Onset of Action | 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment | Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data. | Units on a scale | MEAN |
| PRIMARY | Mean Ocular Itching at 16 Hours Duration of Action | 3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment | Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data. | Units on a scale | MEAN |
| SECONDARY | Mean Conjunctival Redness at Onset of Action | 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment | Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data. | Units on a scale | MEAN |
| SECONDARY | Mean Conjunctival Redness at 16 Hours Duration of Action | 7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment | Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data. | Units on a scale | MEAN |
| SECONDARY | Mean Total Redness at 24 Hours Duration of Action | 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment | Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data. | Units on a scale | MEAN |
| SECONDARY | Mean Ocular Itching at 24 Hours Duration of Action | 3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment | Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data. | Units on a scale | MEAN |
| SECONDARY | Mean Conjunctival Redness at 24 Hours Duration of Action | 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment | Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Ocular Itching at Onset of Action | AL-4943A | 3 min post-CAC | 0.4 | Standard Deviation 0.7 | Units on a scale |
| Mean Ocular Itching at Onset of Action | Vehicle | 3 min post-CAC | 1.9 | Standard Deviation 1.1 | Units on a scale |
| Mean Ocular Itching at Onset of Action | Pataday | 3 min post-CAC | 0.4 | Standard Deviation 0.6 | Units on a scale |
| Mean Ocular Itching at Onset of Action | AL-4943A | 5 min post-CAC | 0.6 | Standard Deviation 0.8 | Units on a scale |
| Mean Ocular Itching at Onset of Action | Vehicle | 5 min post-CAC | 2.1 | Standard Deviation 1.1 | Units on a scale |
| Mean Ocular Itching at Onset of Action | Pataday | 5 min post-CAC | 0.7 | Standard Deviation 0.7 | Units on a scale |
| Mean Ocular Itching at Onset of Action | AL-4943A | 7 min post-CAC | 0.5 | Standard Deviation 0.7 | Units on a scale |
| Mean Ocular Itching at Onset of Action | Vehicle | 7 min post-CAC | 2.0 | Standard Deviation 1.1 | Units on a scale |
| Mean Ocular Itching at Onset of Action | Pataday | 7 min post-CAC | 0.7 | Standard Deviation 0.8 | Units on a scale |
| Mean Ocular Itching at 16 Hours Duration of Action | AL-4943A | 3 min post-CAC | 0.7 | Standard Deviation 0.7 | Units on a scale |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AL-4943A | 66 | |
| Overall Study | STARTED | Vehicle | 68 | |
| Overall Study | STARTED | Pataday | 68 | |
| Overall Study | COMPLETED | AL-4943A | 63 | |
| Overall Study | COMPLETED | Vehicle | 60 | |
| Overall Study | COMPLETED | Pataday | 63 | |
| Overall Study | NOT COMPLETED | AL-4943A | 3 | |
| Overall Study | NOT COMPLETED | Vehicle | 8 | |
| Overall Study | NOT COMPLETED | Pataday | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AL-4943A | ||
| Total, all-cause mortality | Vehicle | ||
| Total, all-cause mortality | Pataday | ||
| Total, other adverse events | AL-4943A | 0 | 66 |
| Total, other adverse events | Vehicle | 0 | 68 |
| Total, other adverse events | Pataday | 0 | 68 |
| Total, serious adverse events | AL-4943A | 0 | 66 |
| Total, serious adverse events | Vehicle | 0 | 68 |
| Total, serious adverse events | Pataday | 0 | 68 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27466061 | 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.
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/NCT01479374
GET https://conductscience.org/api/trials/v1/NCT01479374/results?page=2