Trial · NCT01534195
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
NCT01534195, Phase 4, Completed, ORA, Inc.; results first posted 2019-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model. Trials, record NCT01534195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01534195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
- NCT number
- NCT01534195
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 11 participants, actual
- Lead sponsor
- ORA, Inc.
- Conditions
- Allergic Conjunctivitis
- Interventions
- Prednisolone Sodium Phosphate Ophthalmic Solution 1%, Tears Naturale II Ophthalmic Solution
- First posted
- 2012-02-16
- Last updated
- 2019-03-26
- Results first posted
- 2019-01-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ocular Itching Change From Baseline to Day 11 | 5 minutes post-CAC | Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching). |
| Secondary | Conjunctival Redness Change From Baseline to Day 11 | 7 Minutes post-CAC | Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness) |
| Secondary | Episcleral Redness Change From Baseline to Day 6 | 7 minutes post-CAC | Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness). |
| Secondary | Ciliary Redness Change From Baseline to Day 6 | 7 minutes post-CAC | Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness). |
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 | Ocular Itching Change From Baseline to Day 11 | 5 minutes post-CAC | All participants who completed the study | units on a scale | MEAN |
| SECONDARY | Conjunctival Redness Change From Baseline to Day 11 | 7 Minutes post-CAC | All participants who completed the study | score on a scale | MEAN |
| SECONDARY | Episcleral Redness Change From Baseline to Day 6 | 7 minutes post-CAC | All participants who completed the study | score on a scale | MEAN |
| SECONDARY | Ciliary Redness Change From Baseline to Day 6 | 7 minutes post-CAC | All participants who completed the study | score 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 |
|---|---|---|---|---|---|
| Ocular Itching Change From Baseline to Day 11 | Prednisolone | -1.1 | Standard Deviation 0.14 | units on a scale | |
| Ocular Itching Change From Baseline to Day 11 | Placebo | -0.45 | Standard Deviation 0.86 | units on a scale | |
| Conjunctival Redness Change From Baseline to Day 11 | Prednisolone | -0.69 | Standard Deviation 0.31 | score on a scale | |
| Conjunctival Redness Change From Baseline to Day 11 | Placebo | 0.40 | Standard Deviation 0.88 | score on a scale | |
| Episcleral Redness Change From Baseline to Day 6 | Prednisolone | -1.0 | Standard Deviation 0.41 | score on a scale | |
| Episcleral Redness Change From Baseline to Day 6 | Placebo | 0.45 | Standard Deviation 0.93 | score on a scale | |
| Ciliary Redness Change From Baseline to Day 6 | Prednisolone | -0.94 | Standard Deviation 0.66 | score on a scale | |
| Ciliary Redness Change From Baseline to Day 6 | Placebo | 0.30 | Standard Deviation 0.96 | score 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 | Prednisolone | 5 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | Prednisolone | 4 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Prednisolone | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events6
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 | Mucous Discharge (OU) | Eye disorders | Prednisolone | 0 | 5 | 0 |
| other | Mucous Discharge (OU) | Eye disorders | Placebo | 2 | 6 | 2 |
| other | Headache | Musculoskeletal and connective tissue disorders | Prednisolone | 1 | 5 | 1 |
| other | Headache | Musculoskeletal and connective tissue disorders | Placebo | 0 | 6 | 0 |
| other | Backache | Musculoskeletal and connective tissue disorders | Prednisolone | 0 | 5 | 0 |
| other | Backache | Musculoskeletal and connective tissue disorders | Placebo | 1 | 6 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prednisolone | 0 | 5 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | Prednisolone | 1 | 5 |
| Total, other adverse events | Placebo | 3 | 6 |
| Total, serious adverse events | Prednisolone | 0 | 5 |
| Total, serious adverse events | Placebo | 0 | 6 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prednisolone vs Placebo: deaths from any cause | Trial comparisons |
| Prednisolone vs Placebo: serious adverse events | 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/NCT01534195
GET https://conductscience.org/api/trials/v1/NCT01534195/registered