Handling Comparison Between Two Contact Lens Types

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02310126
• Collaborator: (none)
• Enrollment: 195
• Locations: 8
• Arms: 2
• Actual Duration (Days): 30
• Patients Per Site: 24.4
• Patients Per Site Per Month: 24.7

Study Details

Study Description

Brief Summary

Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: etafilcon A (multi-focal); Device: etafilcon A (sphere)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: etafilcon A(sphere)/etafilcon A(multi-focal) Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.	Device: etafilcon A (multi-focal); Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.; Other Names: Investigational Multifocal Contact ; Device: etafilcon A (sphere); Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.; Other Names: 1-DAY ACUVUE® MOIST®
Active Comparator: etafilcon A(multi-focal)/etafilcon A(sphere) Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.	Device: etafilcon A (multi-focal); Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.; Other Names: Investigational Multifocal Contact ; Device: etafilcon A (sphere); Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.; Other Names: 1-DAY ACUVUE® MOIST®

Outcome Measures

Primary Outcome Measures

1. Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. [15 minutes post Contact Lens Insertion]

   CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. The subject must be between 40 and 70 years of age.

4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.

5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.

6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.

7. The subject best corrected visual acuity of 20/20 -3 or better in each eye.

8. Subject must own a wearable pair of spectacles.

9. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)

10. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

4. Any ocular abnormality that may interfere with contact lens wear.

5. Use of any ocular medication, with the exception of rewetting drops.

6. Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

7. Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.

8. Any ocular infection or inflammation.

9. History of herpetic keratitis.

10. Any corneal distortion or irregular cornea.

11. History of binocular vision abnormality or strabismus.

12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).

13. Current history of diabetes.

14. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baymeadows Vision Center	Jacksonville	Florida	United States	32256
2	Eye Elements Eyecare	Jacksonville	Florida	United States	32256
3	Vistakon Research Clinic	Jacksonville	Florida	United States	32256
4	Golden Family Eyecare	Sarasota	Florida	United States	34232
5	Eye Associates of Winter Park	Winter Park	Florida	United States	32792
6	Central Ohio Eyecare	Columbus	Ohio	United States	43202
7	Optometry Group LLC	Memphis	Tennessee	United States	38111
8	Nashville Vision Associates	Nashville	Tennessee	United States	37205

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02310126
• Other Study ID Numbers: CR-5570
• First Posted: Dec 5, 2014
• Last Update Posted: Jun 19, 2018
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Pre-assignment Detail	This study enrolled a total of 195 subjects. Of those enrolled, 4 subjects did not meet the eligibility criteria, and 191 subjects were dispensed study lenses. Of those dispensed, subjects 189 completed the study and 2 subjects were discontinued. Subjects were stratified as either Hyperops or Myopes based on their sphere power.

Arm/Group Title	Etafilcon A(Multi-focal)/Etafilcon A(Sphere)	Etafilcon A(Sphere)/Etafilcon A(Multi-focal)
Arm/Group Description	Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens.	Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
Period Title: Period 1 (15 Minutes)
STARTED	94	97
Hyperopes	38	33
Myopes	56	64
COMPLETED	94	95
NOT COMPLETED	0	2
Period Title: Period 1 (15 Minutes)
STARTED	94	95
Hyperopes	38	32
Myopes	56	63
COMPLETED	94	95
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Etafilcon A(Multi-focal)/ Etafilcon A(Sphere)	Etafilcon A(Sphere) / Etafilcon A(Multi-focal)	Total
Arm/Group Description	Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens.	Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.	Total of all reporting groups
Overall Participants	94	97	191
Age (years) [Mean (Standard Deviation) ]
Hyperopes, N=38, N=33, N=71	55.2 (7.49)	57.3 (6.45)	56.2 (7.06)
Myopes, N=56, N=64, N=120	50.8 (7.03)	51.1 (7.24)	51.0 (7.12)
Sex: Female, Male (Count of Participants)
Female	70 74.5%	83 85.6%	153 80.1%
Male	24 25.5%	14 14.4%	38 19.9%
Race/Ethnicity, Customized (participants) [Number]
American Indian Or Alaska Native	1 1.1%	0 0%	1 0.5%
Asian	0 0%	1 1%	1 0.5%
Black of African American	4 4.3%	8 8.2%	12 6.3%
Native Hawaiian or Other Pacific Islander	0 0%	1 1%	1 0.5%
White	89 94.7%	87 89.7%	176 92.1%
Region of Enrollment (participants) [Number]
United States	94 100%	97 100%	191 100%

Outcome Measures

1. Primary Outcome

Title	Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
Description	CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Time Frame	15 minutes post Contact Lens Insertion

Outcome Measure Data

Analysis Population Description

The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata.

Arm/Group Title	Etafilcon A(Multi-focal)	Etafilcon A (Sphere)
Arm/Group Description	Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.	Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
Measure Participants	184	184
Hyperopes, N=69, N=69	53.44 (25.482)	55.81 (26.432)
Myopes, N=115, N=115	61.70 (24.594)	60.23 (23.369)

Adverse Events

Time Frame	Throughout the duration of the study (approximately 1 month)
Arm/Group Title	Etafilcon A (Multi-focal)		Etafilcon A (Sphere)
Arm/Group Description	Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.		Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
All Cause Mortality
	Etafilcon A (Multi-focal)		Etafilcon A (Sphere)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Etafilcon A (Multi-focal)		Etafilcon A (Sphere)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/191 (0%)		0/191 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A (Multi-focal)		Etafilcon A (Sphere)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/191 (0%)		0/191 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.