A Clinical Study Comparing the Comfort of Three Commercially Available Contact Lenses

• Sponsor: ORA, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02298400
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the comfort of three commercially available contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Complication	Device: Acuvue® Oasys® Lenses (senofilcon A); Device: 30-Day Bausch + Lomb PureVision (balafilcon A); Device: Clariti® 1-Day (Somofilcon A)	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Single-Center, Cross-over, Pilot Study Evaluating Acuvue® Oasys® Lenses (Senofilcon A), 30-Day Bausch + Lomb PureVision (Balafilcon A), and Clariti® 1-Day (Somofilcon A) Lenses, for Their Impact on Ocular Discomfort Induced by Exposure to the Turbo Controlled Adverse Environment™
• Study Start Date: Aug 1, 2014
• Anticipated Primary Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acuvue®Oasys® Lenses(senofilcon A) Acuvue® Oasys® Lenses (senofilcon A) contact lenses	Device: Acuvue® Oasys® Lenses (senofilcon A); Contact lenses placed in each eye during the day for about 8 hours; Device: 30-Day Bausch + Lomb PureVision (balafilcon A); Contact lenses placed in each eye during the day for about 8 hours; Device: Clariti® 1-Day (Somofilcon A); Contact lenses placed in each eye during the day for about 8 hours
Active Comparator: Bausch + Lomb PureVision (balafilcon A) 30-Day Bausch + Lomb PureVision (balafilcon A) contact lenses	Device: Acuvue® Oasys® Lenses (senofilcon A); Contact lenses placed in each eye during the day for about 8 hours; Device: 30-Day Bausch + Lomb PureVision (balafilcon A); Contact lenses placed in each eye during the day for about 8 hours; Device: Clariti® 1-Day (Somofilcon A); Contact lenses placed in each eye during the day for about 8 hours
Active Comparator: Clariti® 1-Day (Somofilcon A) Clariti® 1-Day (Somofilcon A) contact lenses	Device: Acuvue® Oasys® Lenses (senofilcon A); Contact lenses placed in each eye during the day for about 8 hours; Device: 30-Day Bausch + Lomb PureVision (balafilcon A); Contact lenses placed in each eye during the day for about 8 hours; Device: Clariti® 1-Day (Somofilcon A); Contact lenses placed in each eye during the day for about 8 hours

Outcome Measures

Primary Outcome Measures

1. Contact lens wear comfort, as assessed by subject reported symptoms in diaries. [1 week]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Be at least 18 years old

• Have provided written informed consent

• Have discomfort when wearing contact lenses

Exclusion Criteria:

• Have an active ocular infection or significant slit lamp findings

• Participated in any other studies in the past 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• ORA, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ORA, Inc.
• ClinicalTrials.gov Identifier: NCT02298400
• Other Study ID Numbers: 14-270-0001
• First Posted: Nov 24, 2014
• Last Update Posted: Jan 7, 2015
• Last Verified: Nov 1, 2014

Study Results

No Results Posted as of Jan 7, 2015