On-Eye Evaluation of Contact Lens Axis Location

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100410
• Other study ID #: C-12-061
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: April 18, 2014
• Start date: April 2013
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A toric contact lens T1
Iteration 2-87-1 with embossed mark
• Delefilcon A toric contact lens T2
Iteration 2-87-1 without embossed mark
• Delefilcon A toric contact lens T3
Iteration 2-87-2 with embossed mark
• Delefilcon A toric contact lens T4
Iteration 2-87-2 without embossed mark
• Delefilcon A toric contact lens T5
Iteration 2-87-3 with embossed mark
• Delefilcon A toric contact lens T6
Iteration 2-87-3 without embossed mark

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Lenses With Axis Orientation = 10 Degrees From Ideal Location After 3 Minutes of Wear	Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).	Day 1	No
Secondary	Lens Awareness	Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.	Day 1	No
Secondary	Handling on Removal	Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).	Day 1	No