Phase 3 N=310 Randomized Double-blind Basic Science

Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

Allergic Conjunctivitis

Bottom Line

View on ClinicalTrials.gov: NCT00569777 ↗

Enrolled (actual)

310

Serious AEs

0.7%

Results posted

Nov 2010

Primary outcome: Primary: Lid and Lid Margin Erythema, Change From Baseline — 0; 0 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: K-Lens (generic name not established) and Ketotifen (Device); Placebo Lens (Device)
Age: Pediatric, Adult, Older Adult · 8+ yrs
Sex: All
Sponsor: Vistakon Pharmaceuticals
Primary completion: Feb 2008

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; -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; -0.1	—
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	-0.1; 0	—
PRIMARY Corneal Staining - Temporal, Change From Baseline	0; 0	—
PRIMARY Corneal Staining - Inferior, Change From Baseline	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	-0.3; -0.4	—
PRIMARY Dilated Ophthalmoscopy - Fundus, Change From Baseline	-0.1; 0	—
PRIMARY Dilated Ophthalmoscopy - Vitreous, Change From Baseline	0; 0	—
PRIMARY Visual Acuity Assessment	362; 178	—

Summary

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00569777). 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.