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

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

Study Overview

• Status: Completed
• Conditions: Ocular Comfort
• Intervention / Treatment: Device: Lotrafilcon A test contact lens; Device: Lotrafilcon A control contact lens; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)

Detailed Description

The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • McKnight Building, Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lotrafilcon A test/lotrafilcon A control; 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; Silicone hydrogel single vision, soft contact lens with alternate parameters; Device: Lotrafilcon A control contact lens; Silicone hydrogel single vision, soft contact lens; Other Names: Night&Day; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT); Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear
Other: Lotrafilcon A control/lotrafilcon A test; 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; Silicone hydrogel single vision, soft contact lens with alternate parameters; Device: Lotrafilcon A control contact lens; Silicone hydrogel single vision, soft contact lens; Other Names: Night&Day; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT); Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CIBA VISION
• Collaborators: Bascom Palmer Eye Institute
• Investigators: Principal Investigator: Jianhua Wang, MD, PhD, Bascom Palmer Eye Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 25, 2011
• First Submitted That Met QC Criteria: August 25, 2011
• First Posted (Estimate): August 26, 2011

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 20, 2013
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: P-367-C-800