- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00569777
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
310
Phase
- 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
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California
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Gardena, California, United States, 90247
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Massachusetts
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North Andover, Massachusetts, United States, 01845
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Tennessee
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Memphis, Tennessee, United States, 38119
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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
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 |
Intervention / Treatment |
---|---|
Experimental: K-lens
etafilcon A contact lens with ketotifen.
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combination drug-device product: contact lens (device) and anti-allergy drug
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Placebo Comparator: Placebo
etafilcon A contact lens without ketotifen
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contact lens without drug
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What is the study measuring?
Primary Outcome Measures
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.
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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
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Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
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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.
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baseline and 12 weeks
|
Cells in Anterior Chamber, Change From Baseline
Time Frame: baseline and 12 weeks
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Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
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baseline and 12 weeks
|
Corneal Staining - Nasal, Change From Baseline
Time Frame: baseline and 12 weeks
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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
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Corneal Staining - Inferior, Change From Baseline
Time Frame: baseline and 12 weeks
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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
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Intraocular Pressure, Change From Baseline
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
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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
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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.
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at 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
November 27, 2007
First Submitted That Met QC Criteria
December 6, 2007
First Posted (Estimate)
December 7, 2007
Study Record Updates
Last Update Posted (Estimate)
March 6, 2015
Last Update Submitted That Met QC Criteria
February 18, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctival Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dermatologic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Ketotifen
Other Study ID 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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