Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01120782
• Collaborator: (none)
• Enrollment: 45
• Locations: 2
• Arms: 2
• Patients Per Site: 22.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: etafilcon A toric contact lens with new wetting agent; Device: etafilcon A toric contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Actual Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: etafilcon A toric new lens/etafilcon A toric lens The lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.	Device: etafilcon A toric contact lens with new wetting agent; Investigational toric contact lens made of etafilcon A material with a new wetting agent.; Device: etafilcon A toric contact lens; Marketed toric contact lens made of etafilcon A material.
Active Comparator: etafilcon A toric lens/etafilcon A toric new lens The lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.	Device: etafilcon A toric contact lens with new wetting agent; Investigational toric contact lens made of etafilcon A material with a new wetting agent.; Device: etafilcon A toric contact lens; Marketed toric contact lens made of etafilcon A material.

Outcome Measures

Primary Outcome Measures

1. Prescription Equivalence [after 15 minutes of lens wear]

   Number of subjects whose prescription is the same for the two lenses tested.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The subject must be between 18 and 40 years old.

2. The subject must have normal eyes.

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

4. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

5. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.

6. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.

7. The subject's refractive cylinder axis must be 180 +/- 30 in each eye.

8. The subject must be an adapted wearer of soft toric contact lenses in both eyes.

9. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.

10. Subjects must already possess a wearable pair of spectacles. -

Exclusion Criteria:

1. Ocular or systemic allergies or disease that may interfere with contact lens wear.

2. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.

3. Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.

4. Clinically significant tarsal abnormalities that might interfere with contact lens wear.

5. Any ocular infection.

6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

7. Pregnancy or lactation

8. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

9. Diabetes

10. Strabismus -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Jacksonville	Florida	United States
2		New York	New York	United States

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: NCT01120782
• Other Study ID Numbers: CR-1476AI
• First Posted: May 11, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Pre-assignment Detail	Due to test article shipment error, one clinical site did not receive control test article in a required cylinder and all screened/enrolled subject were unable to be fitted according to the protocol and were discontinued.

Arm/Group Title	All Subjects
Arm/Group Description	All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Period Title: Overall Study
STARTED	45
COMPLETED	34
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Overall Participants	45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.2 (5.10)
Sex: Female, Male (Count of Participants)
Female	13 28.9%
Male	32 71.1%
Region of Enrollment (participants) [Number]
United States	45 100%

Outcome Measures

1. Primary Outcome

Title	Prescription Equivalence
Description	Number of subjects whose prescription is the same for the two lenses tested.
Time Frame	after 15 minutes of lens wear

Outcome Measure Data

Analysis Population Description

All completed subjects.

Arm/Group Title	All Subjects
Arm/Group Description	All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Measure Participants	34
Number [participants]	34 75.6%

Adverse Events

Arm/Group Title	All Subjects
Arm/Group Description	All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
All Cause Mortality
	All Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication requires agreement and written authorization from Sponsor.