Trial · NCT01289431

Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

NCT01289431, Phase 2, Completed, Bausch & Lomb Incorporated; results first posted 2020-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis. Trials, record NCT01289431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01289431

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis
NCT number: NCT01289431
Status: Completed
Phases: Phase 2
Enrollment: 236 participants, actual
Lead sponsor: Bausch & Lomb Incorporated
Conditions: Conjunctivitis, Allergic
Interventions: Mapracorat, Vehicle
First posted: 2011-02-03
Last updated: 2020-09-04
Results first posted: 2020-09-04

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	8 hours	Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Primary	Conjunctival Redness	8 hours	Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.
Secondary	Ciliary Redness	8 hours	The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness.
Secondary	Episcleral Redness	8 hours	Episcleral redness was evaluated by the Investigator using a 0-4 scale with half unit increments allowed. A lower score is indicative of less episcleral 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	8 hours	Participants with results at the 8 hour timepoint are included, with no imputation for missing data.	score on a scale	MEAN
PRIMARY	Conjunctival Redness	8 hours	Participants with results at the 8 hour timepoint are included, with no imputation for missing data.	score on a scale	MEAN
SECONDARY	Ciliary Redness	8 hours	Participants with results at the 8 hour timepoint are included, with no imputation for missing data.	score on a scale	MEAN
SECONDARY	Episcleral Redness	8 hours	Participants with results at the 8 hour timepoint are included, with no imputation for missing data.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Ocular Itching	0.3% Once a Day	1.71	Standard Deviation 1.212	score on a scale
Ocular Itching	2% Once a Day	1.34	Standard Deviation 0.757	score on a scale
Ocular Itching	3% Once a Day	2.11	Standard Deviation 1.196	score on a scale
Ocular Itching	0.3% Twice a Day	2.06	Standard Deviation 0.880	score on a scale
Ocular Itching	2% Twice a Day	1.65	Standard Deviation 0.804	score on a scale
Ocular Itching	3% Twice a Day	1.58	Standard Deviation 0.842	score on a scale
Ocular Itching	Vehicle	2.28	Standard Deviation 0.985	score on a scale
Conjunctival Redness	0.3% Once a Day	2.05	Standard Deviation 0.757	score on a scale
Conjunctival Redness	2% Once a Day	1.56	Standard Deviation 0.723	score on a scale
Conjunctival Redness	3% Once a Day	2.01	Standard Deviation 0.791	score on a scale

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	0.3% Once a Day	34
Overall Study	STARTED	2% Once a Day	34
Overall Study	STARTED	3% Once a Day	34
Overall Study	STARTED	0.3% Twice a Day	33
Overall Study	STARTED	2% Twice a Day	34
Overall Study	STARTED	3% Twice a Day	33
Overall Study	STARTED	Vehicle	34
Overall Study	COMPLETED	0.3% Once a Day	29
Overall Study	COMPLETED	2% Once a Day	32
Overall Study	COMPLETED	3% Once a Day	30

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events35

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
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	0.3% Once a Day	0	34
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	2% Once a Day	0	34
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	3% Once a Day	2	34
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	0.3% Twice a Day	0	33
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	2% Twice a Day	0	34
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	3% Twice a Day	0	33
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	Vehicle	1	34
other	Visual acuity reduced	Eye disorders	0.3% Once a Day	1	34
other	Visual acuity reduced	Eye disorders	2% Once a Day	0	34
other	Visual acuity reduced	Eye disorders	3% Once a Day	0	34

1 to 10 of 35Source ClinicalTrials.gov

See all 35 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	0.3% Once a Day
Total, all-cause mortality	2% Once a Day
Total, all-cause mortality	3% Once a Day
Total, all-cause mortality	0.3% Twice a Day
Total, all-cause mortality	2% Twice a Day
Total, all-cause mortality	3% Twice a Day
Total, all-cause mortality	Vehicle
Total, other adverse events	0.3% Once a Day	1	34
Total, other adverse events	2% Once a Day	0	34
Total, other adverse events	3% Once a Day	4	34

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01289431

GET https://conductscience.org/api/trials/v1/NCT01289431/results?page=2

API reference For AI assistants