Corneal and Conjunctival Sensitivity and Staining Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00455455

Enrollment

Registered

2007-04-03

Start date

2007-03-31

Completion date

2008-12-31

Last updated

2010-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperopia, Myopia

Brief 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.

Detailed description

Interventions

DRUGOptifree RepleniSH Multipurpose Disinfecting Solution

lens care system

DRUGReNu Multiplus Multipurpose Solution

lens care system

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

17 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Conjunctival Sensitivity	baseline	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.
Corneal Sensitivity	baseline	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.

Secondary

Measure	Time frame	Description
Corneal Staining Grade	baseline	A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).

Countries

Canada

Participant flow

Recruitment details

Participants recruited from local communities in Kitchener-Waterloo, Canada between May 2007 and Feb 2008.

Pre-assignment details

64 participants recruited and screened; 14 withdrawn prior to the group assignment due to loss of interest, relocation and inconvenience.

Participants by arm

Arm	Count
Entire Study Group includes groups randomized to use RepleniSH in the 1st period and ReNu in the 2nd period, and first use ReNu and use RepleniSH in the second period.	50
Total	50

Withdrawals & dropouts

Period	Reason	FG000	FG001
Washout	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Entire Study Group
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	50 Participants
Age Continuous	25 years STANDARD_DEVIATION 7
Region of Enrollment Canada	50 participants
Sex: Female, Male Female	35 Participants
Sex: Female, Male Male	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 48	0 / 48
serious Total, serious adverse events	0 / 48	0 / 48

Outcome results

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.

Time frame: baseline