Safety and Comfort of AL-4943A Ophthalmic Solution

February 27, 2015 updated by: Alcon Research

A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%

The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
  • Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
  • History of any clinically significant external ocular disease within 30 days of the start of the study.
  • Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
  • Other protocol-defined 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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Olopatadine, 0.7%
Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
Treatment A
Other Names:
  • AL-4943A
Drug: Olopatadine hydrochloride ophthalmic solution vehicle
Treatment B, inactive ingredients used as placebo
Drug: Ketotifen fumarate ophthalmic solution, 0.025%
Treatment C
Other Names:
  • Zaditor®
Placebo Comparator: Vehicle
Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized
Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
Treatment A
Other Names:
  • AL-4943A
Drug: Olopatadine hydrochloride ophthalmic solution vehicle
Treatment B, inactive ingredients used as placebo
Drug: Ketotifen fumarate ophthalmic solution, 0.025%
Treatment C
Other Names:
  • Zaditor®
Active Comparator: Zaditor
Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized
Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%
Treatment A
Other Names:
  • AL-4943A
Drug: Olopatadine hydrochloride ophthalmic solution vehicle
Treatment B, inactive ingredients used as placebo
Drug: Ketotifen fumarate ophthalmic solution, 0.025%
Treatment C
Other Names:
  • Zaditor®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak discomfort score over a 3-minute period after drop instillation
Time Frame: Up to Day 3
Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed.
Up to Day 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ocular Symptoms
Time Frame: Up to Day 3
Ocular symptoms (burning, stinging, tearing, blurring, and stickiness) assessed by the subject after instillation of drop as a single score where 0=none to 9=severe.
Up to Day 3
Product Acceptability
Time Frame: Up to Day 3
Product Acceptability assessed by the subject after instillation of drop as a single score where 0=very acceptable and 100=not acceptable.
Up to Day 3

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Abhijit Narvekar, MS, MBBS, 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C-10-127

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings