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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889252
• Other study ID #: CR-4539
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2009
• Last updated: February 18, 2015
• Start date: April 2009

Study information

• Verified date: February 2015
• Source: Vistakon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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: 250
• Est. primary completion date: July 2009
• 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, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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

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 conjunctival redness 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, 4=very 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 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	Yes
Primary	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	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, 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	Yes
Primary	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	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 fulid 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 the 12 week visit	Yes