A Six-Week Safety Study of an Investigational Ophthalmic Solution

NCT01698814 | Completed Phase 3 Results

• 1 other identifier: C-12-028
• Study Type: interventional
• Target: 518
• Locations: 0 countries
• Sites: N/A

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

Keywords

ocular safety; allergic conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  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.

  An average of 6 weeks

Study Arms (2)

AL-4943A

EXPERIMENTAL

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

Drug: AL-4943A Ophthalmic Solution

AL-4943A Vehicle

PLACEBO COMPARATOR

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

Drug: AL-4943A Ophthalmic Solution Vehicle

Interventions

AL-4943A Ophthalmic Solution DRUG

AL-4943A

AL-4943A Ophthalmic Solution Vehicle DRUG

Inactive ingredients used as placebo

AL-4943A Vehicle

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Terri Pasquine, Sr. Clinical Project Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Terri Pasquine

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 3, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 27, 2014
• Results First Posted: February 28, 2014

Record last verified: 2014-02