A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily

Alcon Research0 sites518 target enrollmentOctober 2012

ConditionsAllergic Conjunctivitis

InterventionsAL-4943A Ophthalmic Solution AL-4943A Ophthalmic Solution Vehicle

DrugsAL-4943A Ophthalmic Solution AL-4943A Ophthalmic Solution Vehicle

Overview

Phase: Phase 3
Intervention: AL-4943A Ophthalmic Solution
Conditions: Allergic Conjunctivitis
Sponsor: Alcon Research
Enrollment: 518
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

January 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able and willing to comply with study protocol and follow protocol instructions.
•Adequate birth control methods for the duration of the study.
•Best-corrected visual acuity (BCVA) of 55 or greater in each eye.
•Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to Visit 1 and expected to remain the same for the study duration.
•Willing and able to sign an Informed Consent form.
•Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

•Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
•Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC).
•Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to Visit
•Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to Visit
•Current or past history of glaucoma or ocular hypertension.
•History of retinal detachment, diabetic retinopathy, or progressive retinal disease.
•Presence of ocular conditions that may affect the study outcomes.
•Corneal conditions affecting the corneal structure.
•History or evidence of any ocular surgical procedure within 1 year prior to Visit
•Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study.

Arms & Interventions

AL-4943A

AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks

Intervention: AL-4943A Ophthalmic Solution

AL-4943A Vehicle

AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks

Intervention: AL-4943A Ophthalmic Solution Vehicle

Outcomes

Primary Outcomes

Adverse Events

Time Frame: An average of 6 weeks

An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.