Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01024855
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief Summary

A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia; Astigmatism	Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RevitaLens OcuTec Multipurpose Solution (Investigational MPS)	Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control); multi-purpose lens care solution
Active Comparator: Opti-Free RepleniSH Multipurpose Solution (MPS, Control)	Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control); multi-purpose lens care solution

Outcome Measures

Primary Outcome Measures

1. Number of Eyes With No Change in Corneal Staining [Change from baseline after 1, 2, 4 and 6+ hours of wear]

   Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• were at least 18 years old;

• were experienced contact lens wearers;

• were correctable to at least 20/40 or better in both eyes with contact lenses;

• were in good general health, with healthy eyes (other than requiring vision correction);

• had not worn lenses for at least 12 hours before each baseline visit;

• had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;

• had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion Criteria:

• had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;

• required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;

• had a known sensitivity or intolerance to any MPS, study products or ingredient(s);

• were currently participating in any other clinical study;

• had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Medical Optics Inc.	Santa Ana	California	United States	92705

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT01024855
• Other Study ID Numbers: COBR-106-9608
• First Posted: Dec 3, 2009
• Last Update Posted: Oct 20, 2015
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Astigmatism; Hyperopia

Study Results

Participant Flow

Recruitment Details	Recruitment of employees occurred 7/8/2010 - 10/1/2010 thru employee bulletin for study taking place at in-house optometric clinic.
Pre-assignment Detail	Prior to baseline visit subjects were instructed to undergo a "washout period" where no contacts were worn for 12 hours. Slit lamp exam was conducted prior to randomized group assignment. Eyes were thoroughly rinsed with unit-dose aline before pre-soaked study lenses were inserted.

Arm/Group Title	RevitaLens and OptiFree
Arm/Group Description	30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
Period Title: Overall Study
STARTED	30
COMPLETED	29
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	RevitaLens and OptiFree
Arm/Group Description	30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Sex/Gender, Customized (participants) [Number]
Unknown	30 100%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Number of Eyes With No Change in Corneal Staining
Description	Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
Time Frame	Change from baseline after 1, 2, 4 and 6+ hours of wear

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	RevitaLens	OptiFree
Arm/Group Description	30 subjects, one eye received RevitaLens MPS (investigational).	30 subjects, one eye received Opti-Free RepleniSH MPS(control).
Measure Participants	30	30
1 Hour - No Change	16	17
2 Hours - No Change	19	14
4 Hours - No Change	21	21
End of Day (>6 hrs) - No Change	19	20

Adverse Events

Arm/Group Title	RevitaLens and OptiFree
Arm/Group Description	30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
All Cause Mortality
	RevitaLens and OptiFree
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	RevitaLens and OptiFree
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	RevitaLens and OptiFree
	Affected / at Risk (%)	# Events
Total	0/30 (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.