Myopia Clinical Trial
Official title:
The Clinical Performance of the Clariti Contact Lens (Including Handling Tint) for Daily Wear
The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti
Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals
Limited) by comparison with Air Optix Aqua silicone hydrogel lenses (Alcon Inc.)
Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens
maintenance, care and storage.
I. Study characteristics:
The clinical study evaluates the clinical performance of a silicone hydrogel contact lens
for daily wear, Clariti (including handling tint) (Sauflon Pharmaceuticals Ltd.) versus a
predicate device, Air Optix Aqua (Alcon Inc.), in terms of lens performance, physiological
response and subjective acceptance.
Subjects used OptiFRee Replenish solution (Alcon Laboratories Inc.) for daily lens
maintenance, care and storage.
The key features were as follows:
1. One month duration.
2. Three investigator sites.
3. Daily wear soft (hydrophilic) silicone hydrogel contact lenses, replaced on a monthly
basis: Clariti Monthly (with handling tint)and Air Optix Aqua. Replenish was used as a
care system by all subjects.
4. A total of 38 subjects were enrolled, and 38 subjects accounted for 76 eyes were
dispensed lenses. This group was randomized into 25 test subjects (50 eyes) and 13
control subjects (26 eyes).
5. Of the 25 test subjects, 25 (100%) completed one month of use. Of the 13 control
subjects, 12 (92.3%)completed one month of use.
6. There were no adverse reactions.
II. Study period:
The study was conducted over one month of wear. Subjects were examined initially, and at two
follow-up visits after two weeks and four weeks respectively. Study visits commenced on June
26, 2013 and completed on September 14, 2013.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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