Clinical Performance of All-in-One Light Multi-purpose for Silicone Hydrogel Contact Lenses
Condition: Healthy
Study type: Interventional

Summary: 
      A clinical trial was conducted to assess the safety and acceptability of the Sauflon
      Multipurpose Solution when used with four different silicone hydrogel contact lens brands and
      one conventional hydrogel control lens was conducted over a period of two months, with a
      control group using Ciba Vision Aquify Multi- Purpose Solution. The study was conducted at
      six investigator sites and a total of 257 subjects were enrolled. The results of this study
      showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose
      Solution to the predicate device for its intended use.
    

Detailed description: 
      1.1 Study characteristics This study evaluated the safety and efficacy of the All-in-One
      Light multipurpose care regimen (Sauflon Pharmaceuticals Limited) by comparison with the
      Aquify care regimen(Ciba Vision Inc.). Each subject used one of five different lens brands:
      Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision
      Inc.), Acuvue Advance and Acuvue 2 (both Johnson & Johnson).

      The key study features were as follows:

        1. Two months duration.

        2. Six investigator sites.

        3. Daily wear soft (hydrophilic) contact lenses, replaced on a two-weekly basis: Air Optix
           Aqua, PureVision, Biofinity, Acuvue Advance and Acuvue 2; with one of two care regimens:
           All-in-One Light and Aquify.

        4. A total of 257 subjects were enrolled, and 256 subjects accounting for 512 eyes were
           dispensed lenses. This group was randomized into 173 test subjects (346 eyes) and 83
           control subjects (166 eyes).

        5. Of the 173 test subjects, 163 (94.2%) completed two months of use. Of the 83 control
           subjects, 73 (88.0%) completed two months of use.

        6. No eyes remained active at the end of the study.

        7. There were no adverse reactions. 1.2 Study period The study was conducted over two
           months of wear. Subjects were examined initially, and at three follow-up visits after
           two weeks, one month and two months. Study visits commenced on March 29, 2010 and were
           completed on March 11, 2011.

      1.3 Demographics Six investigator sites dispensed 173 test subjects (346 eyes) who used
      All-in-One Light as their care regimen during the work. Also dispensed were 83 control
      subjects (166 eyes)who used Aquify as their care regimen during the work. All recruited
      subjects were existing contact lenses wearers.

      Of the 173 test subjects, 163 (94.2%) completed two months of use and ten (5.8%) were
      discontinued. Of the 83 control subjects, 73 (88.0%) completed two months of use and ten
      (12.2%) were discontinued.

      The enrolled control group was made up of 51 females (61%) and 32 males (39%) with an age
      range from 18 to 67 years (mean 36.7 years). The enrolled test group was composed of 117
      females (67%) and 57 males (33%) with an age range from 18 to 65 years (mean 34.1 years). One
      subject (female, age 45 years) was enrolled and assigned to the test group but was not
      dispensed lenses.
    

Intervention name(s): All-in-One Light multipurpose; Aquify care
Intervention type(s): Device; Device
Intervention description(s): The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months.; The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: AIOL; multipurpose solution; silicone hydrogel lenses; The safety and efficacy of the All-in-One Light multipurpose care regimen by comparison with the Aquify care regimen