Corneal and Conjunctival Sensitivity and Staining Study

• Sponsor: University of Waterloo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00455455
• Collaborator: Alcon Research (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 21.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia	Drug: Optifree RepleniSH Multipurpose Disinfecting Solution; Drug: ReNu Multiplus Multipurpose Solution	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Corneal and Conjunctival Sensitivity and Staining Study
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Optifree RepleniSH Multipurpose Disinfecting Solution	Drug: Optifree RepleniSH Multipurpose Disinfecting Solution; lens care system; Other Names: lens care system
Active Comparator: ReNu Multiplus Multipurpose Solution	Drug: ReNu Multiplus Multipurpose Solution; lens care system; Other Names: lens care system

Outcome Measures

Primary Outcome Measures

1. 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.

2. Corneal Sensitivity [day 7]

   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.

3. 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.

4. Conjunctival Sensitivity [day 7]

   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.

Secondary Outcome Measures

1. Corneal Staining Grade [baseline]

   A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).

2. Corneal Staining Grade [day 7]

   A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Contact Lens Research, School of Optometry	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• University of Waterloo
• Alcon Research

Investigators

• Principal Investigator: Desmond Fonn, M.Optom, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00455455
• Other Study ID Numbers: P/245/06/L
• First Posted: Apr 3, 2007
• Last Update Posted: Jul 12, 2010
• Last Verified: Jun 1, 2010

• Additional relevant MeSH terms: Hyperopia; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Participants recruited from local communities in Kitchener-Waterloo, Canada between May 2007 and Feb 2008.
Pre-assignment Detail	64 participants recruited and screened; 14 withdrawn prior to the group assignment due to loss of interest, relocation and inconvenience.

Arm/Group Title	RepleniSH First, Then ReNu	ReNu First, Then RepleniSH
Arm/Group Description	Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period)	Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period)
Period Title: Washout
STARTED	25	25
COMPLETED	25	24
NOT COMPLETED	0	1
Period Title: Washout
STARTED	25	24
COMPLETED	25	24
NOT COMPLETED	0	0
Period Title: Washout
STARTED	25	24
COMPLETED	24	24
NOT COMPLETED	1	0
Period Title: Washout
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Group
Arm/Group Description	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.
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	50 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25 (7)
Sex: Female, Male (Count of Participants)
Female	35 70%
Male	15 30%
Region of Enrollment (participants) [Number]
Canada	50 100%

Outcome Measures

1. Primary Outcome

Title	Corneal Sensitivity
Description	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.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

intent to treat analysis including only participants who had completed the study

Arm/Group Title	RepleniSH	ReNu
Arm/Group Description	use RepleniSH for lens care in either first period or second period	Use ReNu for lens care in either first period or second period
Measure Participants	48	48
Mean (Standard Deviation) [percent CO2]	26.9 (13.0)	25.5 (12.9)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intent to treat analysis including only participants who had completed the study

Arm/Group Title	RepleniSH	ReNu
Arm/Group Description	use RepleniSH for lens care in either first period or second period	use ReNu for lens care in either first period or second period
Measure Participants	48	48
Mean (Standard Deviation) [units on a scale]	1.3 (2.0)	1.8 (3.0)

3. Primary Outcome

Title	Corneal Sensitivity
Description	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.
Time Frame	day 7

Outcome Measure Data

Analysis Population Description

intent to treat analysis including only participants who had completed the study

Arm/Group Title	RepleniSH	ReNu
Arm/Group Description	use RepleniSH for lens care in either first period or second period	use ReNu for lens care in either first period or second period
Measure Participants	48	48
Mean (Standard Deviation) [percent CO2]	25.5 (13.4)	22.1 (13.8)

4. Secondary Outcome

Title	Corneal Staining Grade
Description	A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).
Time Frame	day 7

Outcome Measure Data

Analysis Population Description

intent to treat analysis including only participants who had completed the study

Arm/Group Title	RepleniSH	ReNu
Arm/Group Description	use RepleniSH for lens care in either first period or second period	use ReNu for lens care in either first period or second period
Measure Participants	48	48
Mean (Standard Deviation) [units on a scale]	4.7 (7.5)	49.9 (39.9)

5. Primary Outcome

Title	Conjunctival Sensitivity
Description	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

Outcome Measure Data

Analysis Population Description

intent to treat analysis including only participants who had completed the study

Arm/Group Title	RepleniSH	ReNu
Arm/Group Description	use RepleniSH for lens care in either first period or second period	Use ReNu for lens care in either first period or second period
Measure Participants	48	48
Mean (Standard Deviation) [percent CO2]	48.7 (20.2)	49.6 (18.7)

6. Primary Outcome

Title	Conjunctival Sensitivity
Description	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	day 7

Outcome Measure Data

Analysis Population Description

intent to treat analysis including only participants who had completed the study

Arm/Group Title	RepleniSH	ReNu
Arm/Group Description	use RepleniSH for lens care in the first period and the second period	use ReNu for lens care in the first period or the second period
Measure Participants	48	48
Mean (Standard Deviation) [percent CO2]	50.5 (20.2)	46.2 (22.4)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	There were no adverse events
Arm/Group Title	RepleniSH		ReNu
Arm/Group Description	use RepleniSH for lens care in either first period or second period		use ReNu for lens care in either first period or second period
All Cause Mortality
	RepleniSH		ReNu
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	RepleniSH		ReNu
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	RepleniSH		ReNu
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)

Limitations/Caveats

Sample size completed as anticipated.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.