GARM: Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00965237
• Collaborator: University of Waterloo (Other)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: lotrafilcon B multifocal contact lens; Device: lotrafilcon B single vision contact lens; Other: Over-reader spectacles	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Multifocal CL / Single vision CL + reading glasses Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.	Device: lotrafilcon B multifocal contact lens; Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use; Device: lotrafilcon B single vision contact lens; Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use; Other: Over-reader spectacles; Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis
Other: Single vision CL + reading glasses / Multifocal CL Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.	Device: lotrafilcon B multifocal contact lens; Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use; Device: lotrafilcon B single vision contact lens; Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use; Other: Over-reader spectacles; Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis

Outcome Measures

Primary Outcome Measures

1. Overall Satisfaction With the Lenses [1 week of wear]

   Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• has discontinued contact lens wear primarily due to age-related, near vision demands

• requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction

• has had an ocular examination in the last 2 years

• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

• has any ocular disease

• has more than a 2.00D prescription difference between eyes

• cannot be fit successfully with the study contact lenses

• has any systemic disease affecting ocular health

• is using any systemic or topical medications that may affect ocular health

• has undergone corneal refractive surgery

• Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo Centre for Contact Lens Research	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• CIBA VISION
• University of Waterloo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT00965237
• Other Study ID Numbers: P-368-C-101
• First Posted: Aug 25, 2009
• Last Update Posted: Jul 10, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Arm/Group Title	Multifocal CL / Single Vision CL+ Reading Glasses	Single Vision CL + Reading Glasses / Multifocal CL
Arm/Group Description	Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.	Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Period Title: Period 1, One Week of Wear
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0
Period Title: Period 1, One Week of Wear
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	This reporting group includes all enrolled and dispensed subjects.
Overall Participants	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.3 (4.5)
Sex: Female, Male (Count of Participants)
Female	12 75%
Male	4 25%

Outcome Measures

1. Primary Outcome

Title	Overall Satisfaction With the Lenses
Description	Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.
Time Frame	1 week of wear

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol

Arm/Group Title	Lotrafilcon B Multifocal Contact Lens	Lotrafilcon B Single Vision Contact Lens + Reading Glasses
Arm/Group Description	Commercially marketed, lotrafilcon B, silicone hydrogel, multifocal contact lens for daily wear use	Commercially marketed, lotrafilcon B, silicone hydrogel, single vision contact lenses for daily wear use, with over-reader spectacles worn as needed
Measure Participants	16	16
Mean (Standard Deviation) [Units on a Scale]	82.5 (14.5)	64.4 (22.9)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial. Individual subject exposure = 1 week per product, total 2 weeks.
Arm/Group Title	Multifocal Contact Lens		Single Vision Contact Lens
Arm/Group Description	Commercially marketed lotrafilcon B multifocal contact lenses		Commercially marketed lotrafilcon B single vision contact lenses
All Cause Mortality
	Multifocal Contact Lens		Single Vision Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Multifocal Contact Lens		Single Vision Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Multifocal Contact Lens		Single Vision Contact Lens
	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.

No distribution of trial-specific information without express written permission of director.