Clinical trial NCT00569777: Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-12-07
Enrollment: 310
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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

Primary outcomes:
measure: Lid and Lid Margin Erythema, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Lid and Lid Margin Swelling, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Conjunctival Redness, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Conjunctival Chemosis, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Edema, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Erosion, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Endothelial, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Lens Pathology, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Flare in Anterior Chamber, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Cells in Anterior Chamber, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Nasal, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Temporal, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Inferior, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Superior, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Central, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Intraocular Pressure, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Dilated Ophthalmoscopy - Fundus, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Dilated Ophthalmoscopy - Vitreous, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Visual Acuity Assessment
timeFrame: at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gardena
country: United States
state: California
city: North Andover
country: United States
state: Massachusetts
city: Memphis
country: United States
state: Tennessee
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Brian Pall, OD, MS, FAAO
role: STUDY_DIRECTOR
References: