NCT01996787

Clinical Study of Visibility Tinted Clariti Contact Lens

The Clinical Performance of the Clariti Contact Lens (Including Handling Tint) for Daily Wear

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Sauflon Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 19 Years – 56 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperopia
• Myopia

Interventions

Type	Name	Description
DEVICE	Air Optix Aqua	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.
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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-07-01
• Completion: 2013-09-01
• First posted: 2013-11-27
• Last updated: 2013-11-27

Locations

1 site across 1 country: United Kingdom