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On-Eye Evaluation of Contact Lens Axis Location

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myopia; Astigmatism; Refractive Error

Intervention: Delefilcon A toric contact lens T1 (Device); Delefilcon A toric contact lens T2 (Device); Delefilcon A toric contact lens T3 (Device); Delefilcon A toric contact lens T4 (Device); Delefilcon A toric contact lens T5 (Device); Delefilcon A toric contact lens T6 (Device)

Phase: N/A

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Joachim Nick, Dipl. Ing., Study Director, Affiliation: Alcon Research

Summary

The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.

Clinical Details

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

Primary outcome: Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear

Secondary outcome:

Lens Awareness

Handling on Removal

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Sign written Informed Consent.

- Best corrected distance visual acuity greater than or equal to 20/25 in each eye.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- History of any ocular surgery or ocular injury within 12 weeks of enrollment for this

study.

- Anterior segment disease, infection, inflammation, or abnormality that

contraindicates contact lens wear.

- History of herpetic keratitis.

- Slit-lamp findings at baseline as specified in the protocol.

- Any use of systemic or ocular medications for which contact lens wear could be

contraindicated, including ocular medications that require instillation during contact lens wear.

- Clinically significant dry eye not responding to treatment.

- History of refractive surgery.

- Other protocol-defined exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: April 2013
Last updated: April 18, 2014

Page last updated: August 23, 2015

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