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The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-lens | Experimental | etafilcon A contact lens with ketotifen. |
|
| Placebo | Placebo Comparator | etafilcon A contact lens without ketotifen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-Lens (generic name not established) and Ketotifen | Device | combination drug-device product: contact lens (device) and anti-allergy drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lid and Lid Margin Erythema, Change From Baseline | 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 | 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 | 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 | 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 | 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 | 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 | Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Pall, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gardena | California | 90247 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | K-lens | etafilcon A contact lens with ketotifen. |
| FG001 | Placebo | etafilcon A contact lens without ketotifen |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | K-lens | etafilcon A contact lens with ketotifen. |
| BG001 | Placebo | etafilcon A contact lens without ketotifen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lid and Lid Margin Erythema, Change From Baseline | Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | K-lens | etafilcon A contact lens with ketotifen. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasal fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | nasal fracture resulting from an accident, unrelated to test article |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall OD MS FAAO | Vistakon | 904-443-1290 |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Placebo Lens | Device | contact lens without drug |
|
| baseline and 12 weeks |
| Lens Pathology, Change From Baseline | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | baseline and 12 weeks |
| Dilated Ophthalmoscopy - Fundus, Change From Baseline | 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 |
| Dilated Ophthalmoscopy - Vitreous, Change From Baseline | 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 | 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 |
| North Andover |
| Massachusetts |
| 01845 |
| United States |
| Memphis | Tennessee | 38119 | United States |
| Lost to Follow-up |
|
| scheduled eye surgery |
|
| did not meet exclusion criteria |
|
| pregnant |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| eyes |
|
|
| Primary | Lid and Lid Margin Swelling, Change From Baseline | Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Conjunctival Redness, Change From Baseline | Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Conjunctival Chemosis, Change From Baseline | Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Corneal Edema, Change From Baseline | Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Corneal Erosion, Change From Baseline | Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Corneal Endothelial, Change From Baseline | Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Analysis includes subjects that completed the 12 week visit per protocol. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Lens Pathology, Change From Baseline | Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Flare in Anterior Chamber, Change From Baseline | Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Cells in Anterior Chamber, Change From Baseline | Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Corneal Staining - Nasal, Change From Baseline | 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. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Corneal Staining - Temporal, Change From Baseline | 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. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Corneal Staining - Inferior, Change From Baseline | 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. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Corneal Staining - Superior, Change From Baseline | 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. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Corneal Staining - Central, Change From Baseline | 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. | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Intraocular Pressure, Change From Baseline | Subjects that completed the study per protocol were included in this analysis. | Posted | Mean | Standard Deviation | mm of mercury | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Dilated Ophthalmoscopy - Fundus, Change From Baseline | 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. | Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects/4 eyes. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Dilated Ophthalmoscopy - Vitreous, Change From Baseline | 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. | Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects / 4 eyes. | Posted | Mean | Standard Deviation | Units on a scale | baseline and 12 weeks | eyes | Participants |
|
|
|
| Primary | Visual Acuity Assessment | 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. | Subjects that completed the study per protocol were included in this analysis. | Posted | Number | Eyes | at 12 weeks | eyes | Participants |
|
|
|
| 2 |
| 206 |
| 11 |
| 206 |
| EG001 | Placebo | etafilcon A contact lens without ketotifen | 0 | 104 | 4 | 104 |
|
| abdominal discomfort requiring hospitalization | Gastrointestinal disorders | Non-systematic Assessment | unrelated to test article |
|
The PI may not publish or publicly present the data and or results of the study without prior approval from Vistakon.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |