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

This study has been completed.
Sponsor:
Collaborator:
Bascom Palmer Eye Institute
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01423773
First received: August 25, 2011
Last updated: June 20, 2013
Last verified: November 2012
  Purpose

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


Condition Intervention
Ocular Comfort
Device: Lotrafilcon A test contact lens
Device: Lotrafilcon A control contact lens
Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Final Comfort [ Time Frame: Day 2, Hour 10 ] [ Designated as safety issue: No ]
    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").


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
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 Name: 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423773

Locations
United States, Florida
McKnight Building, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
CIBA VISION
Bascom Palmer Eye Institute
Investigators
Principal Investigator: Jianhua Wang, MD, PhD Bascom Palmer Eye Institute
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01423773     History of Changes
Other Study ID Numbers: P-367-C-800
Study First Received: August 25, 2011
Results First Received: November 21, 2012
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014