One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00902850
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 27.5

Study Details

Study Description

Brief Summary

The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: SofLens Daily Disposable; Device: Marketed 1 Day Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to 1-Day Acuvue TruEye Lenses
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SofLens Daily Disposable SofLens Daily Disposable Lenses	Device: SofLens Daily Disposable; Lenses to be worn for 8-16 hours
Active Comparator: Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens	Device: Marketed 1 Day Contact Lens; Lenses to be worn for 8-16 hours

Outcome Measures

Primary Outcome Measures

1. Clinical Performance [Insertion, 4 hours & End of Day]

   Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.

• Have no active ocular disease or allergic conjunctivitis.

• Not be using any topical ocular medications.

Exclusion Criteria:

• Participating in a conflicting study.

• Considered by the Investigator to not be a suitable candidate for participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb Research Clinic	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: NCT00902850
• Other Study ID Numbers: ROC2-08-169
• First Posted: May 15, 2009
• Last Update Posted: Mar 2, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	SofLens Daily Disposable	Marketed 1 Day Contact Lens
Arm/Group Description	SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours	Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours
Period Title: Overall Study
STARTED	14	14
COMPLETED	12	12
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	SofLens Daily Disposable	Marketed 1 Day Contact Lens	Total
Arm/Group Description	SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours	Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours	Total of all reporting groups
Overall Participants	14	14	28
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	40	40	40
Sex: Female, Male (Count of Participants)
Female	10 71.4%	11 78.6%	21 75%
Male	4 28.6%	3 21.4%	7 25%
Region of Enrollment (participants) [Number]
United States	14 100%	14 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Clinical Performance
Description	Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.
Time Frame	Insertion, 4 hours & End of Day

Outcome Measure Data

Analysis Population Description

All eligible participants

Arm/Group Title	SofLens Daily Disposable	Marketed 1 Day Contact Lens
Arm/Group Description	SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours	Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours
Measure Participants	12	12
Lens Insertion	98.1	100
4 Hours after insertion	97.5	98.1
End of Day (8-16 hours)	91.9	91.7

Adverse Events

Arm/Group Title	SofLens Daily Disposable		Marketed 1 Day Contact Lens
Arm/Group Description	SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours		Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours
All Cause Mortality
	SofLens Daily Disposable		Marketed 1 Day Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SofLens Daily Disposable		Marketed 1 Day Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	SofLens Daily Disposable		Marketed 1 Day Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (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.