Corneal and Conjunctival Sensitivity and Staining Study

Myopia Clinical Trial

Official title:

Corneal and Conjunctival Sensitivity and Staining Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455455
• Other study ID #: P/245/06/L
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2007
• Last updated: June 9, 2010
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2010
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.

Description:

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor physiology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 45 Years

Eligibility

Inclusion Criteria:

An eligible participant is one who:

• Is between 17-45 years old and has full legal capacity to volunteer.

• Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.

• Is willing and able to follow instructions and maintain the appointment schedule.

• Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)

• Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.

• Has normal binocular vision (no strabismus, no amblyopia).

• Has clear corneas and no active ocular disease.

• Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.

• Has astigmatism less than or equal to -1.00DC.

• Agrees to wear the study lenses on a daily wear basis.

• Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.

Exclusion Criteria:

A person is ineligible if he/she:

• Has undergone corneal refractive surgery.

• Is aphakic.

• Has any active ocular disease.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that may affect ocular health.

• Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.

• Is pregnant or lactating.

• Is participating in any other clinical or research study.

• Has a known clinically significant sensitivity to the contact lens care solutions used in the study.

• Has ocular or systemic allergies that could adversely affect contact lens wear.

• Currently wears lenses on a continuous or extended wear basis.

• Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.

• Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable.

• Is a rigid lens wearer.

• Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Drug:
• Optifree RepleniSH Multipurpose Disinfecting Solution
lens care system
• ReNu Multiplus Multipurpose Solution
lens care system

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, School of Optometry	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Sensitivity	The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.	baseline	No
Primary	Corneal Sensitivity	The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.	day 7	No
Primary	Conjunctival Sensitivity	The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.	baseline	No
Primary	Conjunctival Sensitivity	The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.	day 7	No
Secondary	Corneal Staining Grade	A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).	baseline	No
Secondary	Corneal Staining Grade	A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).	day 7	No