Trial Outcomes & Findings for Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis (NCT NCT01443442)

Results Overview

Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

Change from Baseline in Ocular Itching at 14 Days

Results posted on

2019-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Bepreve 1.5% bepotastine besilate, drops, twice per day, for two weeks bepotastine besilate, 1.5%: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days	Alrex treatment with 0.2 % loteprednol etabonate, drops, four times per day Loteprednol etabonate: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
Overall Study STARTED	12	11
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bepreve n=12 Participants 1.5% bepotastine besilate, drops, twice per day, for two weeks bepotastine besilate, 1.5%: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days	Alrex n=11 Participants treatment with 0.2 % loteprednol etabonate, drops, four times per day Loteprednol etabonate: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days	Total n=23 Participants Total of all reporting groups
Age, Customized	49.3 years STANDARD_DEVIATION 16.3 • n=5 Participants	53.0 years STANDARD_DEVIATION 13.0 • n=7 Participants	51.1 years STANDARD_DEVIATION 2.6 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline in Ocular Itching at 14 Days

Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point.

Outcome measures

Outcome measures
Measure	Bepreve n=12 Participants 1.5% bepotastine besilate, drops, twice per day, for two weeks bepotastine besilate, 1.5%: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days	Alrex n=11 Participants treatment with 0.2 % loteprednol etabonate, drops, four times per day Loteprednol etabonate: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
Change From Baseline in Ocular Itching at 14 Days	2.17 units on a scale Standard Deviation 0.53	1.82 units on a scale Standard Deviation 0.47

Adverse Events

Bepreve

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alrex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jerry R. Paugh, OD, PhD

SCCO at MBKU

Phone: 714-449-7487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60