Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00799422
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 3
• Duration (Months): 3.9
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.

Condition or Disease	Intervention/Treatment	Phase
Conjunctival Staining	Device: Complete Easy Rub; Device: ReNu MultiPlus; Device: Clear Care; Device: Contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Evaluation of Lens Fit, Lens Parameters, and Circumlimbal Conjunctival Staining (CSS) in Normal Patients
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ReNu MultiPlus ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.	Device: ReNu MultiPlus; Commercially marketed contact lens solution for contact lens care; Other Names: ReNu MultiPlus® ; Device: Contact lenses; Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.; Other Names: ACUVUE® OASYS®
Active Comparator: Complete Easy Rub Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.	Device: Complete Easy Rub; Commercially marketed contact lens solution for contact lens care; Other Names: Complete® Easy Rub® ; Device: Contact lenses; Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.; Other Names: ACUVUE® OASYS®
Active Comparator: Clear Care Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.	Device: Clear Care; Commercially marketed contact lens solution for contact lens care; Other Names: Clear Care® ; Device: Contact lenses; Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.; Other Names: ACUVUE® OASYS®

Outcome Measures

Primary Outcome Measures

1. Mean Circumlimbal Conjunctival Staining Score [1 week]

   Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.

Secondary Outcome Measures

1. Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week [Dispense (Day 0), 1 week]

   Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.

2. Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week [Dispense (Day 0), 1 week]

   Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Successfully wearing hydrogel and/or silicone hydrogel contact lenses;

• Read, sign, and date informed consent/HIPAA document;

• Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;

• Willing and able to discontinue contact lens wear when requested during the study;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Evidence or history of ocular disease or pathology;

• One functional eye or a monofit lens;

• Use of concomitant topical ocular prescription or over-the-counter ocular medications;

• History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Alison Ramsey, O.D., Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00799422
• Other Study ID Numbers: M-08-02
• First Posted: Nov 27, 2008
• Last Update Posted: Nov 16, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Alcon Research: Conjunctival Staining; lens parameters; lens fit

Study Results

Participant Flow

Pre-assignment Detail	In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 1 week before switching to the next assigned product. A 36-hour washout preceded each usage period.

Arm/Group Title	ReNu / Complete / Clear Care	Complete / Clear Care / ReNu	Clear Care / ReNu / Complete	ReNu / Clear Care / Complete	Complete / ReNu / Clear Care	Clear Care / Complete / ReNu
Arm/Group Description	ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each	Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each	Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each	ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each	Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each	Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each
Period Title: First Week of Wear
STARTED	4	4	4	5	4	5
COMPLETED	4	4	3	4	4	5
NOT COMPLETED	0	0	1	1	0	0
Period Title: First Week of Wear
STARTED	4	4	3	3	4	4
COMPLETED	4	4	3	3	4	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: First Week of Wear
STARTED	4	4	3	3	4	4
COMPLETED	4	4	3	3	4	4
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Baseline characteristics are presented for all participants completing all three treatment sequences.
Overall Participants	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.6 (10.1)
Sex: Female, Male (Count of Participants)
Female	14 63.6%
Male	8 36.4%

Outcome Measures

1. Primary Outcome

Title	Mean Circumlimbal Conjunctival Staining Score
Description	Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all study visits.

Arm/Group Title	ReNu MultiPlus	Complete Easy Rub	Clear Care
Arm/Group Description	ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.	Complete Easy Rub used for one week as specified in the protocol with study contact lenses.	Clear Care used for one week as specified in the protocol with study contact lenses.
Measure Participants	22	22	22
Mean (Standard Deviation) [Units on a scale]	6.39 (2.30)	5.55 (2.94)	5.68 (1.91)

2. Secondary Outcome

Title	Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week
Description	Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.
Time Frame	Dispense (Day 0), 1 week

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all study visits.

Arm/Group Title	ReNu MultiPlus	Complete Easy Rub	Clear Care
Arm/Group Description	ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.	Complete Easy Rub used for one week as specified in the protocol with study contact lenses.	Clear Care used for one week as specified in the protocol with study contact lenses.
Measure Participants	22	22	22
Mean (Standard Deviation) [mm]	-0.25 (0.16)	-0.27 (0.17)	-0.25 (0.15)

3. Secondary Outcome

Title	Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week
Description	Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.
Time Frame	Dispense (Day 0), 1 week

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed all study visits.

Arm/Group Title	ReNu MultiPlus	Complete Easy Rub	Clear Care
Arm/Group Description	ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.	Complete Easy Rub used for one week as specified in the protocol with study contact lenses.	Clear Care used for one week as specified in the protocol with study contact lenses.
Measure Participants	22	22	22
Mean (Standard Deviation) [mm]	0.15 (0.10)	0.13 (0.11)	0.14 (0.10)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study.
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants.
Arm/Group Title	ReNu MultiPlus		Complete Easy Rub		Clear Care
Arm/Group Description	ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.		Complete Easy Rub used for one week as specified in the protocol with study contact lenses.		Clear Care used for one week as specified in the protocol with study contact lenses.
All Cause Mortality
	ReNu MultiPlus		Complete Easy Rub		Clear Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ReNu MultiPlus		Complete Easy Rub		Clear Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/22 (4.5%)		0/22 (0%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/22 (4.5%)		0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	ReNu MultiPlus		Complete Easy Rub		Clear Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.