Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses

Myopia Clinical Trial

Official title:

Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839318
• Other study ID #: A01336
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: May 21, 2014
• Start date: April 2013
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.

Description:

Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Sign Informed Consent.

• Adapted soft contact lens wearer.

• Willing to wear contact lenses up to 12 hours and attend all study visits.

• Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.

• Contact lens prescription within the power range specified in the protocol.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.

• Any use of systemic or ocular medications that would contraindicate contact lens wear.

• Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.

• Monocular (only 1 eye with functional vision) or fit with only 1 lens.

• History of herpetic keratitis, ocular surgery, or irregular cornea.

• Known pregnancy.

• Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.

• Participation in any clinical study within 30 days of Visit 1.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyperopia
• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Nelfilcon A contact lenses

• Omafilcon A contact lenses

• Etafilcon A contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours	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 contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.	Hour 8	No
Secondary	Total Wettability Score	The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.	Hour 8	No