Objective Testing of Tear Film Stability

• Sponsor: Manhattan Vision Associates (Other)
• Overall Status: Completed
• CT.gov ID: NCT00789529
• Collaborator: Alcon Research (Industry)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 16

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Solutions	Device: Opti-Free® RepleniSH® MPDS; Device: ReNu MultiPlus®	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Objective Testing of Tear Film Stability
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Opti-Free® RepleniSH® MPDS	Device: Opti-Free® RepleniSH® MPDS; soft contact lens disinfecting solution
Active Comparator: 2 Renu MultiPlus®	Device: ReNu MultiPlus®; soft contact lens disinfecting solution

Outcome Measures

Primary Outcome Measures

1. Objective, In-vivo Soft Contact Lens Wettability Index [2 weeks]

   The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.

Secondary Outcome Measures

1. Subject Questionnaire Response [2 weeks]

   Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. The subject must be at least 18 years of age and no more than 80 years of age.

2. The subject must have a best corrected visual acuity of 20/30 or better for each eye.

3. The subject must habitually wear contact lenses.

4. The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.

5. The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.

6. The subject must read understand and sign the Statement of Informed Consent.

7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or disease that might interfere with contact lens wear.

2. Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.

3. Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.

4. Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

5. Any ocular infection.

6. Pregnancy or lactation.

7. Diabetes

8. Infectious diseases (e.g. hepatitis, tuberculosis)

9. Contagious immunosuppressive diseases (e.g. HIV)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MVA/IVR	New York City	New York	United States	10022

Sponsors and Collaborators

• Manhattan Vision Associates
• Alcon Research

Investigators

• Principal Investigator: George Zikos, OS, MS, MVA/IVR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manhattan Vision Associates
• ClinicalTrials.gov Identifier: NCT00789529
• Other Study ID Numbers: CS-101
• First Posted: Nov 13, 2008
• Last Update Posted: May 31, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Manhattan Vision Associates: Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film

Study Results

Participant Flow

Recruitment Details	Recruitment of patients was conducted by approaching the patients seen in the practice.
Pre-assignment Detail	32 subjects were recruited and enrolled in the study. No subjects had to be excluded.

Arm/Group Title	1 - ReNu MultiPlus First, Opti-Free RepleniSH Second	2 - Opti-Free RepleniSH First, ReNu MultiPlus Second
Arm/Group Description	Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period	Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period
Period Title: Overall Study
STARTED	16	16
COMPLETED	15	15
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	1 - ReNu MultiPlus First	2 - Opti-Free RepleniSH First	Total
Arm/Group Description	Used ReNu MultiPlus first, Opti-Free RepleniSH Second	Opti-Free RepleniSH first, ReNu MultiPlus Second	Total of all reporting groups
Overall Participants	16	16	32
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	16 100%	32 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.3 (3.8)	27.4 (5.1)	27.3 (4.4)
Sex: Female, Male (Count of Participants)
Female	13 81.3%	14 87.5%	27 84.4%
Male	3 18.8%	2 12.5%	5 15.6%
Region of Enrollment (participants) [Number]
United States	16 100%	16 100%	32 100%

Outcome Measures

1. Primary Outcome

Title	Objective, In-vivo Soft Contact Lens Wettability Index
Description	The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Per protocol. All participants that completed both arms were analysed.

Arm/Group Title	Opti-Free® RepleniSH® MPDS	Renu MultiPlus®
Arm/Group Description	Used Opti-Free® RepleniSH® MPDS	Used Renu MultiPlus®
Measure Participants	30	30
Mean (Standard Deviation) [wettability index]	-1.82 (2.88)	-1.98 (2.80)

2. Secondary Outcome

Title	Subject Questionnaire Response
Description	Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opti-Free® RepleniSH® MPDS	Renu MultiPlus®
Arm/Group Description	Used Opti-Free® RepleniSH® MPDS	Used Renu MultiPlus®
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	42.7 (7.3)	43.1 (5.0)

Adverse Events

Time Frame	Length of study was 24 to 32 days.
Arm/Group Title	1 - ReNu MultiPlus First		2 - Opti-Free RepleniSH First
Arm/Group Description	Used ReNu MultiPlus first, Opti-Free RepleniSH Second		Opti-Free RepleniSH first, ReNu MultiPlus Second
All Cause Mortality
	1 - ReNu MultiPlus First		2 - Opti-Free RepleniSH First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1 - ReNu MultiPlus First		2 - Opti-Free RepleniSH First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	1 - ReNu MultiPlus First		2 - Opti-Free RepleniSH First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.