Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Completed

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion criteria

No active ocular disease

Treatment and study plan

Bepreve

Drug

One drop, both eyes, twice a day

Placebo

Drug

One drop, both eyes, twice a day

Primary outcomes

Ocular Comfort

Time frame: Day 8 & Day 22

A 4-step grading scale with half unit (1-step) increments allowed:

0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2008
First posted: Jan 4, 2008
Registry last updated: Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed