Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.
Interventions
DEVICEcontact lens with ketotifen
K-Lens (generic name not established) and Ketotifen combination drug-device product
DEVICEcontact lens
Placebo contact lens
Sponsors
Vistakon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining - Inferior, Change From Baseline | 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 |
| Lid and Lid Margin Erythema, Change From Baseline | baseline and 12 weeks | Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe |
| Lid and Lid Margin Swelling, Change From Baseline | baseline and 12 weeks | Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe |
| Conjunctival Redness, Change From Baseline | baseline and 12 weeks | Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe |
| Conjunctival Chemosis, Change From Baseline | 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 |
| Corneal Edema, Change From Baseline | baseline and 12 weeks | Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe |
| Corneal Erosion, Change From Baseline | baseline and 12 weeks | Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe |
| Corneal Endothelial, Change From Baseline | baseline and 12 weeks | Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe |
| Lens Pathology, Change From Baseline | 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 |
| Flare in Anterior Chamber, Change From Baseline | 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 |
| Cells in Anterior Chamber, Change From Baseline | 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 |
| Corneal Staining - Nasal, Change From Baseline | baseline and 12 weeks | Assessment of changes to the surface of the 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 |
| Corneal Staining - Temporal, Change From Baseline | baseline and 12 weeks | Assessment of changes to the surface of the cornea, the region towards the 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 |
| Corneal Staining - Superior, Change From Baseline | baseline and 12 weeks | Assessment of changes to the surface of the cornea, the 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 |
| Corneal Staining - Central, Change From Baseline | baseline and 12 weeks | Assessment of changes to the surface of the cornea, the 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 |
| Intraocular Pressure - Change From Baseline | baseline and 12 weeks | — |
| Dilated Ophthalmoscopy - Fundus, Change From Baseline | 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. |
| Dilated Ophthalmoscopy - Vitreous, Change From Baseline | baseline and 12 weeks | Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe. |
| Visual Acuity Assessment | at the 12 week visit | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| K-Lens Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug | 168 |
| Placebo Lens contact lens without drug | 82 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | K-Lens | Placebo Lens | Total |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 12.48 | 29.3 years STANDARD_DEVIATION 10.77 | 31.5 years STANDARD_DEVIATION 12.03 |
| Region of Enrollment United States | 168 participants | 82 participants | 250 participants |
| Sex: Female, Male Female | 117 Participants | 46 Participants | 163 Participants |
| Sex: Female, Male Male | 51 Participants | 36 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 168 | 0 / 82 |
| serious Total, serious adverse events | 1 / 168 | 0 / 82 |
Outcome results
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Cells in Anterior Chamber, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Cells in Anterior Chamber, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Conjunctival Chemosis, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Conjunctival Chemosis, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
Primary
Conjunctival Redness, Change From Baseline
Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Conjunctival Redness, Change From Baseline | -0.3 Units on a scale | Standard Deviation 0.67 |
| Placebo Lens | Conjunctival Redness, Change From Baseline | -0.1 Units on a scale | Standard Deviation 0.58 |
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Corneal Edema, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Corneal Edema, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Corneal Endothelial, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Corneal Endothelial, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
Primary
Corneal Erosion, Change From Baseline
Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Corneal Erosion, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Corneal Erosion, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
Primary
Corneal Staining - Central, Change From Baseline
Assessment of changes to the surface of the cornea, the 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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Corneal Staining - Central, Change From Baseline | 0 Units on a scale | Standard Deviation 0.19 |
| Placebo Lens | Corneal Staining - Central, Change From Baseline | 0 Units on a scale | Standard Deviation 0.19 |
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Corneal Staining - Inferior, Change From Baseline | -0.1 Units on a scale | Standard Deviation 0.51 |
| Placebo Lens | Corneal Staining - Inferior, Change From Baseline | 0.0 Units on a scale | Standard Deviation 0.43 |
Primary
Corneal Staining - Nasal, Change From Baseline
Assessment of changes to the surface of the 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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Corneal Staining - Nasal, Change From Baseline | 0 Units on a scale | Standard Deviation 0.27 |
| Placebo Lens | Corneal Staining - Nasal, Change From Baseline | 0 Units on a scale | Standard Deviation 0.24 |
Primary
Corneal Staining - Superior, Change From Baseline
Assessment of changes to the surface of the cornea, the 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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Corneal Staining - Superior, Change From Baseline | 0 Units on a scale | Standard Deviation 0.13 |
| Placebo Lens | Corneal Staining - Superior, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
Primary
Corneal Staining - Temporal, Change From Baseline
Assessment of changes to the surface of the cornea, the region towards the 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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Corneal Staining - Temporal, Change From Baseline | 0 Units on a scale | Standard Deviation 0.2 |
| Placebo Lens | Corneal Staining - Temporal, Change From Baseline | 0 Units on a scale | Standard Deviation 0.22 |
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.
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Dilated Ophthalmoscopy - Fundus, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Dilated Ophthalmoscopy - Fundus, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
Primary
Dilated Ophthalmoscopy - Vitreous, Change From Baseline
Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Dilated Ophthalmoscopy - Vitreous, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Dilated Ophthalmoscopy - Vitreous, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Flare in Anterior Chamber, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Flare in Anterior Chamber, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
Primary
Intraocular Pressure - Change From Baseline
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Intraocular Pressure - Change From Baseline | 0.8 mm of mercury | Standard Deviation 2.45 |
| Placebo Lens | Intraocular Pressure - Change From Baseline | 0.6 mm of mercury | Standard Deviation 2.51 |
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Lens Pathology, Change From Baseline | 0 Units on a scale | Standard Deviation 0.23 |
| Placebo Lens | Lens Pathology, Change From Baseline | 0 Units on a scale | Standard Deviation 0.2 |
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Lid and Lid Margin Erythema, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Lid and Lid Margin Erythema, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
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
Time frame: baseline and 12 weeks
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| K-Lens | Lid and Lid Margin Swelling, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
| Placebo Lens | Lid and Lid Margin Swelling, Change From Baseline | 0 Units on a scale | Standard Deviation 0 |
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.
Time frame: at the 12 week visit
Population: Subjects that completed the study per protocol were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| K-Lens | Visual Acuity Assessment | 316 Eyes |
| Placebo Lens | Visual Acuity Assessment | 150 Eyes |