Daily Disposable Contact Lens Tear Film Study

DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01473160

Enrollment

Registered

2011-11-17

Start date

2011-11-30

Completion date

2011-12-31

Last updated

2013-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

DEVICEdelefilcon A contact lens

CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear

DEVICEnarafilcon A contact lens

Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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?

Countries

United Kingdom

Participant flow

Recruitment details

Participants were recruited from one study center in the UK.

Participants by arm

Arm	Count
Overall Study All enrolled participants	9
Total	9

Baseline characteristics

Characteristic	Overall Study
Age Continuous	31 years STANDARD_DEVIATION 7
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 9	0 / 9
serious Total, serious adverse events	0 / 9	0 / 9

Outcome results

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.