Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival Allergen Challenge (CAC).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01289431

Enrollment

236

Registered

2011-02-03

Start date

2011-02-28

Completion date

2011-04-30

Last updated

2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conjunctivitis, Allergic

Brief summary

The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.

Interventions

DRUGMapracorat

administered daily to each eye for 2 weeks following allergen challenge using a CAC model

DRUGVehicle

administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* positive history of ocular allergies and a positive skin test reaction * positive bilateral CAC reaction

Exclusion criteria

* have known contraindications or sensitivities to the use of any of the study medications(s) or their components. * have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters. * had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months; * a known history of retinal detachment, diabetic retinopathy, or active retinal disease; * the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit. * use of any disallowed medications during the period indicated prior to Visit 1 and during the study. * have planned surgery during the trial period or within 30 days after. * have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any type of glaucoma at Visit 1

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
0.3% Once a Day BOL-303242-X dosed in the eye	34
2% Once a Day BOL-303242-X dosed in the eye	34
3% Once a Day BOL-303242-X dosed in the eye	34
0.3% Twice a Day BOL-303242-X dosed in the eye	33
2% Twice a Day BOL-303242-X dosed in the eye	34
3% Twice a Day BOL-303242-X dosed in the eye	33
Vehicle Vehicle of BOL-303242-X dosed in the eye	34
Total	236

Baseline characteristics

Characteristic	0.3% Once a Day	2% Once a Day	3% Once a Day	0.3% Twice a Day	2% Twice a Day	3% Twice a Day	Vehicle	Total
Age, Continuous	36.6 years STANDARD_DEVIATION 10.41	35.4 years STANDARD_DEVIATION 13.62	37.7 years STANDARD_DEVIATION 16.1	31.4 years STANDARD_DEVIATION 11.46	36.0 years STANDARD_DEVIATION 13.82	32.4 years STANDARD_DEVIATION 12.03	35.1 years STANDARD_DEVIATION 13.61	35.0 years STANDARD_DEVIATION 13.13
Sex: Female, Male Female	18 Participants	19 Participants	21 Participants	17 Participants	17 Participants	14 Participants	15 Participants	121 Participants
Sex: Female, Male Male	16 Participants	15 Participants	13 Participants	16 Participants	17 Participants	19 Participants	19 Participants	115 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	1 / 34	0 / 34	4 / 34	1 / 33	2 / 34	2 / 33	7 / 34
serious Total, serious adverse events	0 / 34	0 / 34	0 / 34	0 / 33	0 / 34	0 / 33	0 / 34

Outcome results

Primary

Conjunctival Redness

Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.

Time frame: 8 hours

Population: Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Arm	Measure	Value (MEAN)	Dispersion
0.3% Once a Day	Conjunctival Redness	2.05 score on a scale	Standard Deviation 0.757
2% Once a Day	Conjunctival Redness	1.56 score on a scale	Standard Deviation 0.723
3% Once a Day	Conjunctival Redness	2.01 score on a scale	Standard Deviation 0.791
0.3% Twice a Day	Conjunctival Redness	1.82 score on a scale	Standard Deviation 0.779
2% Twice a Day	Conjunctival Redness	1.72 score on a scale	Standard Deviation 0.828
3% Twice a Day	Conjunctival Redness	1.81 score on a scale	Standard Deviation 0.757
Vehicle	Conjunctival Redness	2.14 score on a scale	Standard Deviation 0.631

Primary

Ocular Itching

Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.

Time frame: 8 hours

Population: Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Arm	Measure	Value (MEAN)	Dispersion
0.3% Once a Day	Ocular Itching	1.71 score on a scale	Standard Deviation 1.212
2% Once a Day	Ocular Itching	1.34 score on a scale	Standard Deviation 0.757
3% Once a Day	Ocular Itching	2.11 score on a scale	Standard Deviation 1.196
0.3% Twice a Day	Ocular Itching	2.06 score on a scale	Standard Deviation 0.88
2% Twice a Day	Ocular Itching	1.65 score on a scale	Standard Deviation 0.804
3% Twice a Day	Ocular Itching	1.58 score on a scale	Standard Deviation 0.842
Vehicle	Ocular Itching	2.28 score on a scale	Standard Deviation 0.985

Secondary

Ciliary Redness

The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness.

Time frame: 8 hours

Population: Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Arm	Measure	Value (MEAN)	Dispersion
0.3% Once a Day	Ciliary Redness	1.88 score on a scale	Standard Deviation 0.903
2% Once a Day	Ciliary Redness	1.39 score on a scale	Standard Deviation 0.86
3% Once a Day	Ciliary Redness	1.89 score on a scale	Standard Deviation 0.875
0.3% Twice a Day	Ciliary Redness	1.60 score on a scale	Standard Deviation 0.85
2% Twice a Day	Ciliary Redness	1.58 score on a scale	Standard Deviation 0.915
3% Twice a Day	Ciliary Redness	1.65 score on a scale	Standard Deviation 0.751
Vehicle	Ciliary Redness	2.02 score on a scale	Standard Deviation 0.78

Secondary

Episcleral Redness

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.

Time frame: 8 hours

Population: Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Arm	Measure	Value (MEAN)	Dispersion
0.3% Once a Day	Episcleral Redness	2.11 score on a scale	Standard Deviation 0.739
2% Once a Day	Episcleral Redness	1.56 score on a scale	Standard Deviation 0.735
3% Once a Day	Episcleral Redness	2.07 score on a scale	Standard Deviation 0.763
0.3% Twice a Day	Episcleral Redness	1.85 score on a scale	Standard Deviation 0.805
2% Twice a Day	Episcleral Redness	1.79 score on a scale	Standard Deviation 0.868
3% Twice a Day	Episcleral Redness	1.97 score on a scale	Standard Deviation 0.772
Vehicle	Episcleral Redness	2.25 score on a scale	Standard Deviation 0.632

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Conjunctival Redness

Ocular Itching

Ciliary Redness

Episcleral Redness