MedDataX Logo

Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients

NCT ID: NCT01174823

Last Updated: 2020-09-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis

NCT00424398

Conjunctivitis, Allergic
COMPLETED PHASE2/PHASE3

Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis

NCT00586664

Allergic Conjunctivitis
COMPLETED PHASE3

Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

NCT00586625

Allergic Conjunctivitis
COMPLETED PHASE3

Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis

NCT00423007

Allergic Conjunctivitis
COMPLETED PHASE3

Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

NCT00241319

Allergic Conjunctivitis
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Conjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bepotastine Besilate Ophthalmic Solution

Group Type EXPERIMENTAL

bepotastine besilate ophthalmic solution

Intervention Type DRUG

sterile ophthalmic solution

Placebo

Group Type PLACEBO_COMPARATOR

placebo comparator ophthalmic solution

Intervention Type DRUG

sterile ophthalmic solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bepotastine besilate ophthalmic solution

sterile ophthalmic solution

Intervention Type DRUG

placebo comparator ophthalmic solution

sterile ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects 12 years of age and older with 2-year history of allergic conjunctivitis

Exclusion Criteria

* No active ocular or nasal infection
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tim McNamara, PharmD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Carr WW, Nayak AS, Ratner PH, Gow JA, McNamara TR, Williams JI; Bepotastine Besilate Ophthalmic Solution 1.5% (Bepreve) Study Group. Efficacy of bepotastine besilate ophthalmic solution 1.5% for seasonal allergic conjunctivitis: a randomized, placebo-controlled, natural exposure, clinical trial. Allergy Asthma Proc. 2013 May-Jun;34(3):247-54. doi: 10.2500/aap.2013.34.3671.

Reference Type DERIVED
PMID: 23484763 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S00041

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis
NCT00244543 COMPLETED PHASE3
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
NCT01330355 TERMINATED PHASE3
Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers
NCT00223951 COMPLETED PHASE3
Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy
NCT07309432 NOT_YET_RECRUITING PHASE3
Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis
NCT02079649 COMPLETED PHASE2
Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis
NCT00364091 COMPLETED PHASE3
Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
NCT01107405 COMPLETED PHASE2
A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis
NCT02492321 COMPLETED PHASE3
A Six-Week Safety Study of an Investigational Ophthalmic Solution
NCT01698814 COMPLETED PHASE3
Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
NCT01023841 COMPLETED PHASE4
Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
NCT01743027 COMPLETED PHASE3
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
NCT03231969 COMPLETED PHASE2
Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
NCT01363700 COMPLETED PHASE3
Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea
NCT01987765 COMPLETED
Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
NCT00905762 COMPLETED PHASE1
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
NCT01479374 COMPLETED PHASE3
Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
NCT03521791 COMPLETED PHASE4
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
NCT03479307 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients
NCT06212973 COMPLETED PHASE3
Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
NCT01877694 COMPLETED PHASE2
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis
NCT05591755 COMPLETED PHASE3
DEXTENZA Therapy for Treatment of Allergic Conjunctivitis
NCT04708821 COMPLETED PHASE4
An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
NCT01037179 COMPLETED PHASE3
Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin
NCT00907426 COMPLETED PHASE3
Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis
NCT01478256 COMPLETED PHASE4