CARDINAL: Visual Performance Investigation of Two Toric Soft Contact Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01858701
• Collaborator: (none)
• Enrollment: 49
• Arms: 2
• Duration (Months): 5

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Astigmatism; Myopia; Hyperopia	Device: Lotrafilcon B toric contact lens; Device: Comfilcon A toric contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Visual Performance Investigation of Two Toric Soft Contact Lenses
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: AO for Astig / Biofinity Toric Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.	Device: Lotrafilcon B toric contact lens; Commercially available, silicone hydrogel contact lens for correction of astigmatism; Other Names: AIR OPTIX® for ASTIGMATISM ; Device: Comfilcon A toric contact lens; Commercially available, silicone hydrogel contact lens for correction of astigmatism; Other Names: Biofinity® Toric
Other: Biofinity Toric / AO for Astig Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.	Device: Lotrafilcon B toric contact lens; Commercially available, silicone hydrogel contact lens for correction of astigmatism; Other Names: AIR OPTIX® for ASTIGMATISM ; Device: Comfilcon A toric contact lens; Commercially available, silicone hydrogel contact lens for correction of astigmatism; Other Names: Biofinity® Toric

Outcome Measures

Primary Outcome Measures

1. Mean Ocular Coma Score at 5mm Pupil at Day 30 [Day 30]

   Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Sign informed consent;

• Wears toric soft contact lenses;

• Can be successfully fit with study lenses within the power ranges available;

• Has cylinder of ≥ -0.75 diopter in both eyes;

• Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;

• Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular condition that would contraindicate contact lens wear;

• Use of medications for which contact lens wear could be contraindicated;

• Monocular (only 1 eye with functional vision) or fit with 1 lens;

• History of herpetic keratitis, ocular surgery, or irregular cornea;

• Known sensitivity to the diagnostic pharmaceuticals to be used in the study;

• Requires presbyopic correction;

• Use of rewetting/lubricating eye-drops more than twice a day;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Jessie Lemp, MS, Alcon Research
• Principal Investigator: Lyndon Jones, PhD, School of Optometry and Vision Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01858701
• Other Study ID Numbers: A01335; P/438/13/L
• First Posted: May 21, 2013
• Last Update Posted: Oct 22, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Alcon Research: myopia; hyperopia; astigmatism; contact lenses
• Additional relevant MeSH terms: Myopia; Astigmatism; Refractive Errors; Hyperopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 study center located in Canada.
Pre-assignment Detail	Of the 49 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (40).

Arm/Group Title	AO for Astig / Biofinity Toric	Biofinity Toric / AO for Astig
Arm/Group Description	Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.	Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.
Period Title: Period 1, First 30 Days of Wear
STARTED	20	20
COMPLETED	20	19
NOT COMPLETED	0	1
Period Title: Period 1, First 30 Days of Wear
STARTED	20	19
COMPLETED	18	17
NOT COMPLETED	2	2
Period Title: Period 1, First 30 Days of Wear
STARTED	18	17
COMPLETED	18	16
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Overall Participants	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28 (8.2)
Sex: Female, Male (Count of Participants)
Female	36 73.5%
Male	13 26.5%

Outcome Measures

1. Primary Outcome

Title	Mean Ocular Coma Score at 5mm Pupil at Day 30
Description	Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants who completed the study.

Arm/Group Title	Air Optix for Astig	Biofinity Toric
Arm/Group Description	Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.	Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
Measure Participants	34	34
Mean (Standard Deviation) [micrometers]	0.16 (0.09)	0.24 (0.11)

Adverse Events

Time Frame	Adverse Events (AE) were collected for the duration of the study (5 months). An AE was defined as any undesirable medical occurrence which occurs in an individual participating in a clinical trial, whether or not it is considered to be trial-related.
Adverse Event Reporting Description	This analysis population includes all participants dispensed with study products, based on treatment-specific exposure.
Arm/Group Title	Air Optix for Astig		Biofinity Toric
Arm/Group Description	Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.		Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
All Cause Mortality
	Air Optix for Astig		Biofinity Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Air Optix for Astig		Biofinity Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Air Optix for Astig		Biofinity Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.