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

Ocular Comfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423773
• Other study ID #: P-367-C-800
• Status: Completed
• Phase: N/A
• First received: August 25, 2011
• Last updated: June 20, 2013
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Ocular Comfort

Intervention

Device:
• Lotrafilcon A test contact lens
Silicone hydrogel single vision, soft contact lens with alternate parameters
• Lotrafilcon A control contact lens
Silicone hydrogel single vision, soft contact lens
• Ultra-High Resolution Optical Coherence Tomographer (OCT)
Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear

Locations

Country	Name	City	State
United States	McKnight Building, Bascom Palmer Eye Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	Bascom Palmer Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No