The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
K-Lens (generic name not established) and Ketotifen combination drug-device product
Placebo contact lens
Unnamed facility
Memphis, Tennessee, United States
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
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
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
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
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
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
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
Lens Pathology, Change From Baseline
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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
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
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
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
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
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
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
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
Intraocular Pressure - Change From Baseline
Time frame: 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.
Time frame: baseline and 12 weeks
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
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