Multifocal High ADD Contact Lens Proof of Concept Trial

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02117544
• Collaborator: (none)
• Enrollment: 268
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: Lotrafilcon B multifocal contact lenses (new); Device: Lotrafilcon B multifocal contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 268 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: New MF, then AOAMF Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour.	Device: Lotrafilcon B multifocal contact lenses (new); Device: Lotrafilcon B multifocal contact lenses; Other Names: AIR OPTIX® AQUA Multifocal AOAMF
Other: AOAMF, then New MF Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour.	Device: Lotrafilcon B multifocal contact lenses (new); Device: Lotrafilcon B multifocal contact lenses; Other Names: AIR OPTIX® AQUA Multifocal AOAMF

Outcome Measures

Primary Outcome Measures

1. High Contrast Visual Acuity (HCVA) Near Monocular [Day 1, 10 minutes after lens insertion, each product]

   Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

Secondary Outcome Measures

1. HCVA Distance Monocular [Day 1, 10 minutes after lens insertion, each product]

   Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

2. HCVA Intermediate Monocular [Day 1, 10 minutes after lens insertion, each product]

   Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

3. Low Contrast Visual Acuity (LCVA) Distance Monocular [Day 1, 10 minutes after lens insertion, each product]

   Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must sign an Informed Consent document;

• Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;

• Current or previous soft contact lens wearer;

• Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;

• Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;

• Manifest cylinder less than or equal to 1.00 D;

• Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;

• Any history of herpetic keratitis;

• History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;

• Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade

1. or severe (Grade 4);

• Corneal vascularization that is mild (Grade 2) or higher;

• A pathologically dry eye that precludes contact lens wear;

• Monocular (only 1 eye with functional vision);

• Anisometropia ≥ 1.50 D (contact lens distance prescription);

• Clinically significant (> 1 millimeter) anisocoria;

• History of intolerance or hypersensitivity to any component of the investigational products;

• Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;

• Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;

• Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the study lenses or affect the results of this study;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. Clinical Manager, Vision Care, GCRA, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02117544
• Other Study ID Numbers: C-13-057
• First Posted: Apr 21, 2014
• Last Update Posted: Aug 26, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Alcon Research: Contact lens; Presbyopia; Multifocal
• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 7 study centers located in the US.
Pre-assignment Detail	Of the 268 enrolled, 159 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (109).

Arm/Group Title	New MF, Then AOAMF	AOAMF, Then New MF
Arm/Group Description	Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.	Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
Period Title: Period 1
STARTED	54	55
Treated	52	55
COMPLETED	52	55
NOT COMPLETED	2	0
Period Title: Period 1
STARTED	52	55
COMPLETED	52	55
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Overall Participants	107
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.6 (5.0)
Sex: Female, Male (Count of Participants)
Female	91 85%
Male	16 15%

Outcome Measures

1. Primary Outcome

Title	High Contrast Visual Acuity (HCVA) Near Monocular
Description	Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame	Day 1, 10 minutes after lens insertion, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).

Arm/Group Title	New MF	AOAMF
Arm/Group Description	Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour	Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Measure Participants	104	104
Measure Eyes	208	208
Least Squares Mean (Standard Error) [logMAR]	0.18 (0.02)	0.32 (0.02)

2. Secondary Outcome

Title	HCVA Distance Monocular
Description	Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame	Day 1, 10 minutes after lens insertion, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).

Arm/Group Title	New MF	AOAMF
Arm/Group Description	Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour	Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Measure Participants	104	104
Measure Eyes	208	208
Least Squares Mean (Standard Error) [logMAR]	0.11 (0.01)	0.06 (0.01)

3. Secondary Outcome

Title	HCVA Intermediate Monocular
Description	Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame	Day 1, 10 minutes after lens insertion, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).

Arm/Group Title	New MF	AOAMF
Arm/Group Description	Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour	Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Measure Participants	104	104
Measure Eyes	208	208
Least Squares Mean (Standard Error) [logMAR]	0.04 (0.01)	0.02 (0.01)

4. Secondary Outcome

Title	Low Contrast Visual Acuity (LCVA) Distance Monocular
Description	Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Time Frame	Day 1, 10 minutes after lens insertion, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).

Arm/Group Title	New MF	AOAMF
Arm/Group Description	Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour	Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Measure Participants	104	104
Measure Eyes	208	208
Least Squares Mean (Standard Error) [logMAR]	0.44 (0.01)	0.39 (0.01)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (3 months). AEs are reported as pre-treatment and treatment-emergent, based on treatment-specific exposure.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
Arm/Group Title	Pre-treatment		New MF		AOAMF
Arm/Group Description	Includes all enrolled subjects/eyes prior to exposure to the investigational products		Includes all subjects/eyes exposed to New MF		Includes all subjects/eyes exposed to AOAMF
All Cause Mortality
	Pre-treatment		New MF		AOAMF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Pre-treatment		New MF		AOAMF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/268 (0%)		0/107 (0%)		0/107 (0%)
Other (Not Including Serious) Adverse Events
	Pre-treatment		New MF		AOAMF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/268 (0%)		0/107 (0%)		0/107 (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.