A Six-Week Safety Study of an Investigational Ophthalmic Solution

February 27, 2014 updated by: Alcon Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

518

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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.
  • Other protocol-specified exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AL-4943A
AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
Drug: AL-4943A Ophthalmic Solution
PLACEBO_COMPARATOR: AL-4943A Vehicle
AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
Drug: AL-4943A Ophthalmic Solution Vehicle
Inactive ingredients used as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
An average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Terri Pasquine, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (ESTIMATE)

October 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-12-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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