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

Not Applicable

Completed

• Conditions: Ocular Comfort
• Interventions: Device: Lotrafilcon A test contact lens; Device: Lotrafilcon A control contact lens; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)

• Registration Number: NCT01423773
• Lead Sponsor: CIBA VISION

Brief Summary

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

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-11
• Results First Submitted: 2012-11-21
• Results First Submitted QC: 2012-11-21
• Results First Posted: 2012-12-21
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lotrafilcon A test/lotrafilcon A control	Lotrafilcon A test contact lens	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.
Lotrafilcon A test/lotrafilcon A control	Lotrafilcon A control contact lens	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.
Lotrafilcon A test/lotrafilcon A control	Ultra-High Resolution Optical Coherence Tomographer (OCT)	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.
Lotrafilcon A control/lotrafilcon A test	Lotrafilcon A test contact lens	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.
Lotrafilcon A control/lotrafilcon A test	Lotrafilcon A control contact lens	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.
Lotrafilcon A control/lotrafilcon A test	Ultra-High Resolution Optical Coherence Tomographer (OCT)	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.

Primary Outcome Measures

Name	Time	Method
Final Comfort	Day 2, Hour 10	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").

Trial Locations

Locations (1)

McKnight Building, Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States