Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

February 18, 2015 updated by: Vistakon Pharmaceuticals

A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers

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.

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.
310

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 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Gardena, California, United States, 90247
    • Massachusetts
      • North Andover, Massachusetts, United States, 01845
    • Tennessee
      • Memphis, Tennessee, United States, 38119

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy normal, soft contact lens wearing volunteers
  • normal ocular health
  • contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye

Exclusion Criteria:

  • active ocular infection
  • history of ocular surgery
  • use of topical ophthalmic preparations (including rewetting drops)
  • pregnancy or lactation

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel 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: K-lens
etafilcon A contact lens with ketotifen.
Device: K-Lens (generic name not established) and Ketotifen
combination drug-device product: contact lens (device) and anti-allergy drug
Placebo Comparator: Placebo
etafilcon A contact lens without ketotifen
Device: Placebo Lens
contact lens without drug

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
Dilated Ophthalmoscopy - Fundus, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
baseline and 12 weeks
Lid and Lid Margin Erythema, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Lid and Lid Margin Swelling, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Conjunctival Redness, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Conjunctival Chemosis, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Corneal Edema, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Corneal Erosion, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
baseline and 12 weeks
Corneal Endothelial, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Lens Pathology, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Flare in Anterior Chamber, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Cells in Anterior Chamber, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Corneal Staining - Nasal, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of changes to the surface of cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Corneal Staining - Temporal, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of changes to the surface of the cornea, the region towards the outer edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Corneal Staining - Inferior, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Corneal Staining - Superior, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of changes to the surface of the cornea, upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Corneal Staining - Central, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of changes to the surface of the cornea, central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
baseline and 12 weeks
Intraocular Pressure, Change From Baseline
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Dilated Ophthalmoscopy - Vitreous, Change From Baseline
Time Frame: baseline and 12 weeks
Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
baseline and 12 weeks
Visual Acuity Assessment
Time Frame: at 12 weeks
Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.
at 12 weeks

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.
Vistakon Pharmaceuticals

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.
October 1, 2007

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.
February 1, 2008

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.
March 1, 2008

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).
November 27, 2007

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.
December 6, 2007

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.
December 7, 2007

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 6, 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 18, 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

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.
  • 07-003-002

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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