Trial Outcomes & Findings for Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis (NCT NCT01289431)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

236 participants

Primary outcome timeframe

8 hours

Results posted on

2020-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	0.3% Once a Day BOL-303242-X dosed in the eye	2% Once a Day BOL-303242-X dosed in the eye	3% Once a Day BOL-303242-X dosed in the eye	0.3% Twice a Day BOL-303242-X dosed in the eye	2% Twice a Day BOL-303242-X dosed in the eye	3% Twice a Day BOL-303242-X dosed in the eye	Vehicle Vehicle of BOL-303242-X dosed in the eye
Overall Study STARTED	34	34	34	33	34	33	34
Overall Study COMPLETED	29	32	30	28	32	31	33
Overall Study NOT COMPLETED	5	2	4	5	2	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.3% Once a Day n=34 Participants BOL-303242-X dosed in the eye	2% Once a Day n=34 Participants BOL-303242-X dosed in the eye	3% Once a Day n=34 Participants BOL-303242-X dosed in the eye	0.3% Twice a Day n=33 Participants BOL-303242-X dosed in the eye	2% Twice a Day n=34 Participants BOL-303242-X dosed in the eye	3% Twice a Day n=33 Participants BOL-303242-X dosed in the eye	Vehicle n=34 Participants Vehicle of BOL-303242-X dosed in the eye	Total n=236 Participants Total of all reporting groups
Age, Continuous	36.6 years STANDARD_DEVIATION 10.41 • n=5 Participants	35.4 years STANDARD_DEVIATION 13.62 • n=7 Participants	37.7 years STANDARD_DEVIATION 16.10 • n=5 Participants	31.4 years STANDARD_DEVIATION 11.46 • n=4 Participants	36.0 years STANDARD_DEVIATION 13.82 • n=21 Participants	32.4 years STANDARD_DEVIATION 12.03 • n=10 Participants	35.1 years STANDARD_DEVIATION 13.61 • n=115 Participants	35.0 years STANDARD_DEVIATION 13.13 • n=6 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	17 Participants n=4 Participants	17 Participants n=21 Participants	14 Participants n=10 Participants	15 Participants n=115 Participants	121 Participants n=6 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants	17 Participants n=21 Participants	19 Participants n=10 Participants	19 Participants n=115 Participants	115 Participants n=6 Participants

PRIMARY outcome

Timeframe: 8 hours

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

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

Outcome measures

Outcome measures
Measure	2% Twice a Day n=33 Participants BOL-303242-X dosed in the eye	Vehicle n=33 Participants Vehicle of BOL-303242-X dosed in the eye	0.3% Once a Day n=30 Participants BOL-303242-X dosed in the eye	2% Once a Day n=33 Participants BOL-303242-X dosed in the eye	3% Once a Day n=30 Participants BOL-303242-X dosed in the eye	0.3% Twice a Day n=28 Participants BOL-303242-X dosed in the eye	3% Twice a Day n=31 Participants BOL-303242-X dosed in the eye
Ocular Itching	1.65 score on a scale Standard Deviation 0.804	2.28 score on a scale Standard Deviation 0.985	1.71 score on a scale Standard Deviation 1.212	1.34 score on a scale Standard Deviation 0.757	2.11 score on a scale Standard Deviation 1.196	2.06 score on a scale Standard Deviation 0.880	1.58 score on a scale Standard Deviation 0.842

PRIMARY outcome

Timeframe: 8 hours

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

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

Outcome measures

Outcome measures
Measure	2% Twice a Day n=33 Participants BOL-303242-X dosed in the eye	Vehicle n=33 Participants Vehicle of BOL-303242-X dosed in the eye	0.3% Once a Day n=30 Participants BOL-303242-X dosed in the eye	2% Once a Day n=33 Participants BOL-303242-X dosed in the eye	3% Once a Day n=30 Participants BOL-303242-X dosed in the eye	0.3% Twice a Day n=28 Participants BOL-303242-X dosed in the eye	3% Twice a Day n=31 Participants BOL-303242-X dosed in the eye
Conjunctival Redness	1.72 score on a scale Standard Deviation 0.828	2.14 score on a scale Standard Deviation 0.631	2.05 score on a scale Standard Deviation 0.757	1.56 score on a scale Standard Deviation 0.723	2.01 score on a scale Standard Deviation 0.791	1.82 score on a scale Standard Deviation 0.779	1.81 score on a scale Standard Deviation 0.757

SECONDARY outcome

Timeframe: 8 hours

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

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

Outcome measures

Outcome measures
Measure	2% Twice a Day n=33 Participants BOL-303242-X dosed in the eye	Vehicle n=33 Participants Vehicle of BOL-303242-X dosed in the eye	0.3% Once a Day n=30 Participants BOL-303242-X dosed in the eye	2% Once a Day n=33 Participants BOL-303242-X dosed in the eye	3% Once a Day n=30 Participants BOL-303242-X dosed in the eye	0.3% Twice a Day n=28 Participants BOL-303242-X dosed in the eye	3% Twice a Day n=31 Participants BOL-303242-X dosed in the eye
Ciliary Redness	1.58 score on a scale Standard Deviation 0.915	2.02 score on a scale Standard Deviation 0.780	1.88 score on a scale Standard Deviation 0.903	1.39 score on a scale Standard Deviation 0.860	1.89 score on a scale Standard Deviation 0.875	1.60 score on a scale Standard Deviation 0.850	1.65 score on a scale Standard Deviation 0.751

SECONDARY outcome

Timeframe: 8 hours

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

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.