Daily Disposable Contact Lens Tear Film Study

Myopia Clinical Trial

Official title:

DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473160
• Other study ID #: P-347-C-014v2
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: April 16, 2013
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• 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.

• 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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• delefilcon A contact lens
CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear
• narafilcon A contact lens
Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.

Locations

Country	Name	City	State
United Kingdom	Aston University	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	Aston University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Corrected Visual Acuity of 0.0 or Better	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.	Up to 16 hours after lens insertion	No
Primary	Pre-Lens Noninvasive Tear Break-Up Time	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.	Up to 16 hours after lens insertion	No
Primary	Average Tear Meniscus Height	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.	Up to 16 hours after lens insertion	No
Primary	Average Ocular Surface Temperature	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.	Up to 16 hours after lens insertion	No
Secondary	Subjective Comfort	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?"	Up to 16 hours after lens insertion	No
Secondary	Subjective Vision	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?"	Up to 16 hours after lens insertion	No
Secondary	Number of Participants With Adequate Lens Fit	Lens fit was assessed by the investigator with a biomicroscope (slit lamp).	Up to 16 hours after lens insertion	No