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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
38
Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
Eurolens Research Faculty of Life Sciences The University of Manchester
Manchester, Manchester, United Kingdom
Slit lamp Biomicroscopy
Slit Lamp examination will be performed at the initial and follow-up visits. Slit lamp findings will be graded on a 0-4 scale (0=none;4=severe).
Time frame: 1 month
Adverse reactions
Adverse reactions will be recorded throughout the study. Adverse recations will be classified as serious, significant and non-significant.
Time frame: 1 month
Wear Time
Lens wear time is recorded for the two study lenses at follow-up visits.
Time frame: 1 month
Visual Acuity
LogMAR Visual Acuity at high contrast will be recorded before and after performeing an over-refraction at the initial, two-week and one-month visits.
Time frame: 1 month
Subjective Scores
Subjective scores for comfort, vision, handling and overall score will be recorded at the initial and follow-up visits. The subjective scores will be graded on a 0-5 scale.
Time frame: 1 month
Symptoms, problems and complaints
The presence or absence of symptoms, problems and complaints will be recorded at two-weeks and one-month visits.
Time frame: 1 month
Discontinuations
All subjects discontinuations will be recorded at the two-week and one-month visits.
Time frame: 1 month
Refraction
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Refraction was undertaken and recorded for all subjects at the initial, two-weeks and one-month visits.
Time frame: 1 month
Keratometry
Keratometry measures will be performed at the initial and one-month visits for all subjects.
Time frame: 1 month