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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569777
• Other study ID #: 07-003-002
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2007
• Last updated: February 18, 2015
• Start date: October 2007
• Est. completion date: March 2008

Study information

• Verified date: February 2015
• Source: Vistakon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Device:
• K-Lens (generic name not established) and Ketotifen
combination drug-device product: contact lens (device) and anti-allergy drug
• Placebo Lens
contact lens without drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	Conjunctival Redness, Change From Baseline	Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.	baseline and 12 weeks	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Corneal Erosion, Change From Baseline	Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.	baseline and 12 weeks	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Corneal Staining - Nasal, Change From Baseline	Assessment of changes to the surface of 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	Yes
Primary	Corneal Staining - Temporal, Change From Baseline	Assessment of changes to the surface of the cornea, the region towards the outer 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	Yes
Primary	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	Yes
Primary	Corneal Staining - Superior, Change From Baseline	Assessment of changes to the surface of the cornea, 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	Yes
Primary	Corneal Staining - Central, Change From Baseline	Assessment of changes to the surface of the cornea, 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	Yes
Primary	Intraocular Pressure, Change From Baseline		baseline and 12 weeks	Yes
Primary	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	Yes
Primary	Dilated Ophthalmoscopy - Vitreous, Change From Baseline	Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.	baseline and 12 weeks	Yes
Primary	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 12 weeks	No