Trial · NCT01743027
Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
NCT01743027, Phase 3, Completed, Alcon Research; results first posted 2014-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis. Trials, record NCT01743027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01743027
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
- NCT number
- NCT01743027
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 902 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Allergic Conjunctivitis
- Interventions
- AL-4943A ophthalmic solution, Olopatadine hydrochloride ophthalmic solution, 0.2%, Olopatadine hydrochloride ophthalmic solution, 0.1%, AL-4943A ophthalmic solution vehicle
- First posted
- 2012-12-06
- Last updated
- 2014-08-11
- Results first posted
- 2014-08-11
Source ClinicalTrials.gov
Registered outcomes8
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 | Day 14 (3, 5, and 7 minutes post-CAC) | A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. |
| Primary | Mean Ocular Itching at 24 Hours Duration of Action | Day 1 (3, 5, and 7 minutes post-CAC) | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. |
| Secondary | Mean Conjunctival Redness at Onset of Action | Day 14 (7, 15, and 20 minutes post-CAC) | A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. |
| Secondary | Mean Conjunctival Redness at 24 Hours Duration of Action | Day 1 (7, 15, and 20 minutes post-CAC) | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. |
| Secondary | Mean Total Redness at Onset of Action | Day 14 (7, 15, and 20 minutes post-CAC) | A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. |
| Secondary | Mean Total Redness at 24 Hours Duration of Action | Day 1 (7, 15, and 20 minutes post-CAC) | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. |
| Secondary | Proportion of Ocular Itching Responders at Onset of Action | Day 14 | A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. |
| Secondary | Proportion of Itch Responders at 24 Hours Duration of Action | Day 1 | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. |
Source ClinicalTrials.gov
Outcomes8
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 | Day 14 (3, 5, and 7 minutes post-CAC) | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Ocular Itching at 24 Hours Duration of Action | Day 1 (3, 5, and 7 minutes post-CAC) | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Conjunctival Redness at Onset of Action | Day 14 (7, 15, and 20 minutes post-CAC) | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Conjunctival Redness at 24 Hours Duration of Action | Day 1 (7, 15, and 20 minutes post-CAC) | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Total Redness at Onset of Action | Day 14 (7, 15, and 20 minutes post-CAC) | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Total Redness at 24 Hours Duration of Action | Day 1 (7, 15, and 20 minutes post-CAC) | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Ocular Itching Responders at Onset of Action | Day 14 | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Itch Responders at 24 Hours Duration of Action | Day 1 | Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group80
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 minutes post-CAC | 0.38 | Standard Error 0.069 | units on a scale |
| Mean Ocular Itching at Onset of Action | PATADAY | 3 minutes post-CAC | 0.47 | Standard Error 0.069 | units on a scale |
| Mean Ocular Itching at Onset of Action | PATANOL | 3 minutes post-CAC | 0.59 | Standard Error 0.070 | units on a scale |
| Mean Ocular Itching at Onset of Action | Vehicle | 3 minutes post-CAC | 1.91 | Standard Error 0.095 | units on a scale |
| Mean Ocular Itching at Onset of Action | AL-4943A | 5 minutes post-CAC | 0.53 | Standard Error 0.075 | units on a scale |
| Mean Ocular Itching at Onset of Action | PATADAY | 5 minutes post-CAC | 0.61 | Standard Error 0.075 | units on a scale |
| Mean Ocular Itching at Onset of Action | PATANOL | 5 minutes post-CAC | 0.79 | Standard Error 0.076 | units on a scale |
| Mean Ocular Itching at Onset of Action | Vehicle | 5 minutes post-CAC | 1.99 | Standard Error 0.103 | units on a scale |
| Mean Ocular Itching at Onset of Action | AL-4943A | 7 minutes post-CAC | 0.65 | Standard Error 0.081 | units on a scale |
| Mean Ocular Itching at Onset of Action | PATADAY | 7 minutes post-CAC | 0.61 | Standard Error 0.082 | units on a scale |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AL-4943A | 98 | |
| Overall Study | STARTED | PATADAY | 99 | |
| Overall Study | STARTED | PATANOL | 99 | |
| Overall Study | STARTED | Vehicle | 49 | |
| Overall Study | COMPLETED | AL-4943A | 93 | |
| Overall Study | COMPLETED | PATADAY | 94 | |
| Overall Study | COMPLETED | PATANOL | 90 | |
| Overall Study | COMPLETED | Vehicle | 48 | |
| Overall Study | NOT COMPLETED | AL-4943A | 5 | |
| Overall Study | NOT COMPLETED | PATADAY | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AL-4943A | ||
| Total, all-cause mortality | PATADAY | ||
| Total, all-cause mortality | PATANOL | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | AL-4943A | 0 | 98 |
| Total, other adverse events | PATADAY | 0 | 99 |
| Total, other adverse events | PATANOL | 0 | 99 |
| Total, other adverse events | Vehicle | 0 | 49 |
| Total, serious adverse events | AL-4943A | 0 | 98 |
| Total, serious adverse events | PATADAY | 0 | 99 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01743027
GET https://conductscience.org/api/trials/v1/NCT01743027/results?page=2