A Six-Week Safety Study of an Investigational Ophthalmic Solution

NCT ID: NCT01698814

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-01-31

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

AL-4943A

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

Group Type: EXPERIMENTAL

AL-4943A Ophthalmic Solution

Intervention Type: DRUG

AL-4943A Vehicle

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

Group Type: PLACEBO_COMPARATOR

AL-4943A Ophthalmic Solution Vehicle

Intervention Type: DRUG

Inactive ingredients used as placebo

Interventions

AL-4943A Ophthalmic Solution

Intervention Type: DRUG

AL-4943A Ophthalmic Solution Vehicle

Inactive ingredients used as placebo

Intervention Type: DRUG

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.

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 1.
• 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 1.
• 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 1.
• Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study.
• Prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation.
• Participation in any investigational study within 30 days prior to Visit 1 or concomitantly with this study.
• Known contraindications or hypersensitivities to any of the study medications or their components.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terri Pasquine

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-028

Identifier Type: -

Identifier Source: org_study_id