Daily Disposable Contact Lens Tear Film Study

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: delefilcon A contact lens; Device: narafilcon A contact lens

• Registration Number: NCT01473160
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-11-19
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-14
• Results First Posted: 2013-01-16
• Last Update Submitted: 2013-04-16
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Be of legal age of consent and sign Informed Consent document.
• Willing and able to wear spherical contact lenses for 16 hours.
• Willing and able to wear spherical contact lenses within the available range of powers.
• Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Anterior segment infection, inflammation, or abnormality.
• Any use of systemic medications for which contact lens wear could be contraindicated.
• History of refractive surgery or irregular cornea.
• Currently enrolled in any clinical trial.
• Eye injury within twelve weeks prior to enrollment.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
delefilcon A	delefilcon A contact lens	Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).
narafilcon A	narafilcon A contact lens	Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Corrected Visual Acuity of 0.0 or Better	Up to 16 hours after lens insertion	Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.
Pre-Lens Noninvasive Tear Break-Up Time	Up to 16 hours after lens insertion	The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.
Average Tear Meniscus Height	Up to 16 hours after lens insertion	The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.
Average Ocular Surface Temperature	Up to 16 hours after lens insertion	Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.

Secondary Outcome Measures

Name	Time	Method
Subjective Comfort	Up to 16 hours after lens insertion	Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"
Subjective Vision	Up to 16 hours after lens insertion	Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, "What is the quality of your vision with the lens at present?"
Number of Participants With Adequate Lens Fit	Up to 16 hours after lens insertion	Lens fit was assessed by the investigator with a biomicroscope (slit lamp).

Trial Locations

Locations (1)

Aston University; 🇬🇧 Birmingham, United Kingdom