NCT00889252

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 23, 2010

Completed
Last Updated

March 6, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

April 24, 2009

Results QC Date

October 4, 2010

Last Update Submit

February 18, 2015

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (19)

  • 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

    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

    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

    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

    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

    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

    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

    baseline and 12 weeks

  • Lens Pathology, Change From Baseline

    Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

    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

    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

    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

    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

    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

    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

    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

    baseline and 12 weeks

  • Intraocular Pressure - Change From Baseline

    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.

    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.

    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.

    at the 12 week visit

Study Arms (2)

K-Lens

EXPERIMENTAL

Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug

Device: contact lens with ketotifen

Placebo Lens

PLACEBO COMPARATOR

Placebo lens

Device: contact lens

Interventions

contact lens with ketotifenDEVICE

K-Lens (generic name not established) and Ketotifen combination drug-device product

K-Lens
contact lensDEVICE

Placebo contact lens

Placebo Lens

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • active ocular infection
  • history of ocular surgery
  • use of topical ophthalmic preparations (including rewetting drops)
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Memphis, Tennessee, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Results Point of Contact

Title
Brian Pall OD MS FAAO
Organization
Vistakon
904-443-1290

Study Officials

  • Brian Pall, OD, MS, FAAO

    Johnson & Johnson Vision Care, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 28, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2009

Last Updated

March 6, 2015

Results First Posted

November 23, 2010

Record last verified: 2015-02

Locations

US(1)