Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

NCT01423773 | Completed Results

• 1 other identifier: P-367-C-800
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare the fit and comfort of two types of contact lenses.

Conditions

Ocular Comfort

Outcome Measures

Primary Outcomes (1)

• Final Comfort

  Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").

  Day 2, Hour 10

Study Arms (2)

Lotrafilcon A test/lotrafilcon A control

OTHER

Lotrafilcon A test contact lens worn first, with lotrafilcon A control contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2.

Device: Lotrafilcon A test contact lens; Device: Lotrafilcon A control contact lens; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)

Lotrafilcon A control/lotrafilcon A test

OTHER

Lotrafilcon A control contact lens worn first, with lotrafilcon A test contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2.

Device: Lotrafilcon A test contact lens; Device: Lotrafilcon A control contact lens; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)

Interventions

Lotrafilcon A test contact lens DEVICE

Silicone hydrogel single vision, soft contact lens with alternate parameters

Lotrafilcon A control/lotrafilcon A test; Lotrafilcon A test/lotrafilcon A control

Lotrafilcon A control contact lens DEVICE

Silicone hydrogel single vision, soft contact lens

Also known as: Night&Day

Lotrafilcon A control/lotrafilcon A test; Lotrafilcon A test/lotrafilcon A control

Ultra-High Resolution Optical Coherence Tomographer (OCT) DEVICE

Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear

Lotrafilcon A control/lotrafilcon A test; Lotrafilcon A test/lotrafilcon A control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of legal age of consent and sign Informed Consent document.
• Normal binocularity.
• Be able to wear soft contact lenses.
• Willing to comply with the wear and study visit schedule.
• Spherical contact lens prescription within 0.50 diopter of the available lens powers.
• Spectacle cylinder less than or equal to 1.50 diopter.

You may not qualify if:

• Eye injury or surgery within twelve weeks of enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.

Sponsors & Collaborators

• CIBA VISION: lead
• Bascom Palmer Eye Institute: collaborator

Study Sites (1)

McKnight Building, Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Limitations and Caveats

The sample size may be small for establishing relationship between ocular comfort and other measurable variables.

Results Point of Contact

• Title: Head, Clinical Trial Management
• Organization: Alcon Research

1-800-241-7629

Study Officials

• Jianhua Wang, MD, PhD

  Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 26, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 28, 2013
• Results First Posted: December 21, 2012

Record last verified: 2012-11

Locations

US (1)