Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01416272
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 22.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Device: KeraSoft IC Soft Contact Lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KeraSoft IC Soft Contact Lenses KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care	Device: KeraSoft IC Soft Contact Lenses; Lenses will be worn between 8 and 16 hrs each day, for 12 months

Outcome Measures

Primary Outcome Measures

1. Comfort [4 visits over 1 year]

   Symptoms and complaints measured on an analog scale

Secondary Outcome Measures

1. Visual Acuity - Low Contrast [4 visits over 1 year]

   Low contrast visual acuity measured with high ambient illumination (LCHI)

2. Visual Acuity - High Contrast [4 visits over 1 year]

   High contrast visual acuity measured with high ambient illumination (HCHI)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have participated and completed a previous study (ROC2-10-078).

• Is Keratoconic

Exclusion Criteria:

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

• Is not correctable to 20/50 or better in each eye with contact lenses.

• Has greater than Grade 2 slit lamp exam findings.

• Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.

• Has any neovascularization within the central 4mm of the cornea.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb Incorporated	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01416272
• Other Study ID Numbers: ROC2-11-024
• First Posted: Aug 15, 2011
• Last Update Posted: Nov 25, 2014
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Keratoconus

Study Results

Participant Flow

Arm/Group Title	KeraSoft IC Soft Contact Lenses
Arm/Group Description	KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
Period Title: Overall Study
STARTED	12
COMPLETED	8
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	KeraSoft IC Soft Contact Lenses
Arm/Group Description	KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
Overall Participants	12
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	48
Sex: Female, Male (Count of Participants)
Female	5 41.7%
Male	7 58.3%

Outcome Measures

1. Primary Outcome

Title	Comfort
Description	Symptoms and complaints measured on an analog scale
Time Frame	4 visits over 1 year

Outcome Measure Data

Analysis Population Description

DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.

Arm/Group Title	KeraSoft IC Soft Contact Lenses
Arm/Group Description	KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
Measure Participants	0

2. Secondary Outcome

Title	Visual Acuity - Low Contrast
Description	Low contrast visual acuity measured with high ambient illumination (LCHI)
Time Frame	4 visits over 1 year

Outcome Measure Data

Analysis Population Description

DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.

Arm/Group Title	KeraSoft IC Soft Contact Lenses
Arm/Group Description	KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
Measure Participants	0

3. Secondary Outcome

Title	Visual Acuity - High Contrast
Description	High contrast visual acuity measured with high ambient illumination (HCHI)
Time Frame	4 visits over 1 year

Outcome Measure Data

Analysis Population Description

DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.

Arm/Group Title	KeraSoft IC Soft Contact Lenses
Arm/Group Description	KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
Measure Participants	0

Adverse Events

Arm/Group Title	KeraSoft IC Soft Contact Lenses
Arm/Group Description	KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
All Cause Mortality
	KeraSoft IC Soft Contact Lenses
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	KeraSoft IC Soft Contact Lenses
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	KeraSoft IC Soft Contact Lenses
	Affected / at Risk (%)	# Events
Total	0/12 (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.