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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00889252
First received: April 24, 2009
Last updated: September 26, 2011
Last verified: September 2011

April 24, 2009
September 26, 2011
April 2009
July 2009   (final data collection date for primary outcome measure)
  • Lid and Lid Margin Erythema, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Assessment of conjunctival redness 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Endothelial, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
  • Corneal Staining - Temporal, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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
  • Corneal Staining - Inferior, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
  • Corneal Staining - Central, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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
  • Intraocular Pressure - Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
  • Dilated Ophthalmoscopy - Fundus, Change From Baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • Visual Acuity Assessment [ Time Frame: at the 12 week visit ] [ Designated as safety issue: Yes ]
    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.
adverse events [ Time Frame: baseline, 1 week, monthly ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00889252 on ClinicalTrials.gov Archive Site
Not Provided
  • biomicroscopy [ Time Frame: baseline, 1 week, monthly ] [ Designated as safety issue: Yes ]
  • visual acuity [ Time Frame: baseline, 1 week, monthly ] [ Designated as safety issue: Yes ]
  • ophthalmoscopy [ Time Frame: baseline, monthly ] [ Designated as safety issue: Yes ]
  • intraocular pressure [ Time Frame: baseline, monthly ] [ Designated as safety issue: Yes ]
  • physical exam [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • pupil reactivity [ Time Frame: baseline, 1 week, monthly ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
A Single-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • Device: contact lens with ketotifen
    K-Lens (generic name not established) and Ketotifen combination drug-device product
  • Device: contact lens
    Placebo contact lens
  • Experimental: K-Lens
    Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
    Intervention: Device: contact lens with ketotifen
  • Placebo Comparator: Placebo Lens
    Placebo lens
    Intervention: Device: contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Not Provided
July 2009   (final data collection date for primary outcome measure)

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
Both
8 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889252
CR-4539
No
Vistakon Pharmaceuticals
Vistakon Pharmaceuticals
Not Provided
Study Director: Brian Pall, OD, MS, FAAO Vistakon
Vistakon Pharmaceuticals
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP