N/A Completed N=100 Randomized Double-blind Other

Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Myopia

Source: ClinicalTrials.gov NCT01707238 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcomePrimary: Handling — 8.84; 6.76 units on a scale

Summary

The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Outcome Measures

Outcome	Result	p-value
PRIMARY Handling	8.84; 6.76	—
PRIMARY Satisfaction With Handling	65; 28; 22; 31; 8; 13	—
SECONDARY Comfort	8.84; 8.09	—
SECONDARY Dryness	8.51; 8.07	—
SECONDARY Satisfaction With Dryness	58; 35; 30; 43; 5; 8	—
SECONDARY Satisfaction With Comfort	65; 51; 27; 26; 3; 13	—

Eligibility Criteria

Inclusion Criteria:-

Be between 16 and 45 years of age (inclusive)
Adapted soft contact lens (CL) wearers (i.e. > 1 month)
Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
Correctable to 6/9 (20/30) in both eyes
Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
Have read, understood and signed the informed consent
Willing to comply with the wear schedule (at least 40 hours per week)
Willing to comply with the study visit schedule

Exclusion Criteria:-

Any active corneal infection, injury or inflammation
Systemic or ocular allergies, which might interfere with CL wear
Systemic disease, which might interfere with CL wear
Ocular disease, which might interfere with CL wear
Strabismus, amblyopia
Subjects who have undergone corneal refractive surgery and any anterior segment surgery
Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Pregnant or lactating
Use of systemic/topical medication contraindicating CL wear
Use of gas permeable contact lenses within the last month
Employees of the investigational site or immediate family members of Investigators
Participation in any concurrent clinical trial or in the last 30 days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01707238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.