An interventional study of Air Optix Aqua and Clariti with Handling Tint in Hyperopia and Myopia, sponsored by Sauflon Pharmaceuticals Ltd. Completed at 1 site in United Kingdom. Open to participants aged 19 Years to 56 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-27.
Sponsored by Sauflon Pharmaceuticals Ltd (part of CooperCompanies) · Not applicable and Interventional
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:
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.
144 studies on the registry are indexed under Hyperopia; 18 are open to participants now.
This study's enrollment of 38 is below the median of 59 across 116 interventional studies indexed under Hyperopia.
Browse Hyperopia studies →Sauflon Pharmaceuticals Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.
First submitted before Sauflon Pharmaceuticals Ltd became part of CooperCompanies.
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Exclusion Criteria:
Compare safety and efficacy of the lens using OptiFree Replenish solution
Device: Air Optix Aqua · Device: Clariti with Handling Tint
Compare safety and efficacy of the lens using OptiFree Replenish solution
Device: Air Optix Aqua · Device: Clariti with Handling Tint
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.
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
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
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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