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

• ClinicalTrials.gov Identifier: NCT00889252
• Recruitment Status: Completed
• First Posted: April 28, 2009
• Results First Posted: November 23, 2010
• Last Update Posted: March 6, 2015
• Sponsor: Vistakon Pharmaceuticals
• Information provided by (Responsible Party): Vistakon Pharmaceuticals

Tracking Information

• First Submitted Date: April 24, 2009
• First Posted Date: April 28, 2009
• Results First Submitted Date: October 4, 2010
• Results First Posted Date: November 23, 2010
• Last Update Posted Date: March 6, 2015
• Study Start Date: April 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2010)

• Lid and Lid Margin Erythema, Change From Baseline [ Time Frame: baseline and 12 weeks ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
• Dilated Ophthalmoscopy - Fundus, Change From Baseline [ Time Frame: baseline and 12 weeks ]
  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 ]
  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 ]
  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.

• Original Primary Outcome Measures (submitted: April 27, 2009): adverse events [ Time Frame: baseline, 1 week, monthly ]
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: April 27, 2009)

• biomicroscopy [ Time Frame: baseline, 1 week, monthly ]
• visual acuity [ Time Frame: baseline, 1 week, monthly ]
• ophthalmoscopy [ Time Frame: baseline, monthly ]
• intraocular pressure [ Time Frame: baseline, monthly ]
• physical exam [ Time Frame: baseline, 12 weeks ]
• pupil reactivity [ Time Frame: baseline, 1 week, monthly ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
• Official Title: 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
• Brief Summary: The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Allergic Conjunctivitis

Intervention

• Device: contact lens with ketotifen
  K-Lens (generic name not established) and Ketotifen combination drug-device product
• Device: contact lens
  Placebo contact lens

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2009): 250
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00889252
• Other Study ID Numbers: CR-4539
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Vistakon Pharmaceuticals
• Original Responsible Party: Brian Pall, OD, MS, FAAO/Study Director, Vistakon
• Current Study Sponsor: Vistakon Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Brian Pall, OD, MS, FAAO; Johnson & Johnson Vision Care, Inc.

• PRS Account: Vistakon Pharmaceuticals
• Verification Date: February 2015