Phase 3
Completed N=250
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Source: ClinicalTrials.gov NCT00889252 ↗Enrolled (actual)
250
Serious AEs
0.4%
Results posted
Nov 2010
Primary outcomePrimary: Lid and Lid Margin Erythema, Change From Baseline — 0; 0 Units on a scale
Summary
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lid and Lid Margin Erythema, Change From Baseline |
0; 0 | — |
| PRIMARY Lid and Lid Margin Swelling, Change From Baseline |
0; 0 | — |
| PRIMARY Conjunctival Redness, Change From Baseline |
-0.3; -0.1 | — |
| PRIMARY Conjunctival Chemosis, Change From Baseline |
0; 0 | — |
| PRIMARY Corneal Edema, Change From Baseline |
0; 0 | — |
| PRIMARY Corneal Erosion, Change From Baseline |
0; 0 | — |
| PRIMARY Corneal Endothelial, Change From Baseline |
0; 0 | — |
| PRIMARY Lens Pathology, Change From Baseline |
0; 0 | — |
| PRIMARY Flare in Anterior Chamber, Change From Baseline |
0; 0 | — |
| PRIMARY Cells in Anterior Chamber, Change From Baseline |
0; 0 | — |
| PRIMARY Corneal Staining - Nasal, Change From Baseline |
0; 0 | — |
| PRIMARY Corneal Staining - Temporal, Change From Baseline |
0; 0 | — |
| PRIMARY Corneal Staining - Inferior, Change From Baseline |
-0.1; 0.0 | — |
| PRIMARY Corneal Staining - Superior, Change From Baseline |
0; 0 | — |
| PRIMARY Corneal Staining - Central, Change From Baseline |
0; 0 | — |
| PRIMARY Intraocular Pressure - Change From Baseline |
0.8; 0.6 | — |
| PRIMARY Dilated Ophthalmoscopy - Fundus, Change From Baseline |
0; 0 | — |
| PRIMARY Dilated Ophthalmoscopy - Vitreous, Change From Baseline |
0; 0 | — |
| PRIMARY Visual Acuity Assessment |
316; 150 | — |
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
Data sourced from ClinicalTrials.gov (NCT00889252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.