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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Allergic Conjunctivitis
- Sponsor
- Vistakon Pharmaceuticals
- Enrollment
- 310
- Primary Endpoint
- Lid and Lid Margin Erythema, Change From Baseline
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Intraocular Pressure, Change From Baseline
Time Frame: baseline and 12 weeks
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.
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.
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.