Clinical Comparison of Two Daily Disposable Toric Lenses

NCT01362894 — Not applicable, Completed, 240 participants, CIBA VISION

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Registry	NCT01362894
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	240 (Actual)
Sponsor	CIBA VISION (Industry)
Conditions	Myopia, Astigmatism
Interventions	nelfilcon A contact lens, etafilcon A contact lens (Device)
Dates	start 2011-05-01, primary completion 2011-08-01, completion 2011-08-01, first posted 2011-06-01, last updated 2012-08-09

-Summary

The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

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+Detailed description

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

+Arms and interventions

Arm	Type	Interventions	Description
nelfilcon A / etafilcon A	Other	Device: nelfilcon A contact lens; Device: etafilcon A contact lens	Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
etafilcon A / nelfilcon A	Other	Device: nelfilcon A contact lens; Device: etafilcon A contact lens	Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

nelfilcon A contact lens (Device), also known as Focus® DAILIES® Toric: Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.
etafilcon A contact lens (Device), also known as 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM: Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.

+Outcome measures

Primary outcomes

Overall Vision [1 week, replacing lenses daily]: As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort [1 week, replacing lenses daily]: As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling [1 week, replacing lenses daily]: As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Overall Satisfaction [1 week, replacing lenses daily]: As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary outcomes

Ease of Selecting Final Lens Power [Day 0]: As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Sign written informed consent.
* Germany: Be of legal age.
* Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Wears contact lenses overnight while sleeping.
* Habitual daily disposable contact lens wearer.
* Monovision correction during the study.
* Other protocol-defined exclusion criteria may apply.

+Posted results

Participant flow

Milestone	Nelfilcon A / Etafilcon A	Etafilcon A / Nelfilcon A
Started	119	117
Completed	119	117
Not completed	0	0

Outcome results

Overall Vision (Primary), Mean, Units on a scale: Nelfilcon A 8.2 +/- 1.7; Etafilcon A 7.5 +/- 2.1
Overall Comfort (Primary), Mean, Units on a scale: Nelfilcon A 7.8 +/- 1.8; Etafilcon A 7.2 +/- 2.0
Overall Handling (Primary), Mean, Units on a scale: Nelfilcon A 8.2 +/- 1.8; Etafilcon A 6.8 +/- 2.2
Overall Satisfaction (Primary), Mean, Units on a scale: Nelfilcon A 7.7 +/- 1.9; Etafilcon A 6.9 +/- 2.0
Ease of Selecting Final Lens Power (Secondary), Mean, Units on a scale: Nelfilcon A 8.4 +/- 1.5; Etafilcon A 8.8 +/- 1.2

Adverse events

Time frame: Adverse events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011.

Arm	Deaths	Serious adverse events	Other adverse events
Nelfilcon A	0	2/234 (0.9%)	0/234 (0.0%)
Etafilcon A	0	0/235 (0.0%)	0/235 (0.0%)

Serious adverse events by term

Term	Organ system	Nelfilcon A	Etafilcon A
Appendicitis	Surgical and medical procedures	1/234	0/235
Foot injury requiring hospitalization	Musculoskeletal and connective tissue disorders	1/234	0/235