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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014