NCT01392950

Clinical Study of Clariti Monthly Contact Lens

Clinical Performance of the Clariti Monthly Contact Lens for Daily Wear

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sauflon Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 19 Years – 63 Years
• Healthy volunteers: Accepted

Summary

A clinical study report follows; this clinical study evaluated the safety and efficacy of SAUFLON CLARITI Soft Silicone Hydrogel Contact Lens with UV Blocker by comparison with Air Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.). Subjects used OptiFree Replenish solution (Alcon Laboratories Inc.) for daily lens maintenance, care and storage.

Detailed description

1.1 Study characteristics This study evaluated the safety and efficacy of Clariti Monthly silicone hydrogel contact lenses (Sauflon Pharmaceuticals Limited) by comparison with Air Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.). Subjects used OptiFree Replenish solution(Alcon Laboratories Inc.) for daily lens maintenance, care and storage. The key study features were as follows: 1. Three months duration. 2. Seven investigator sites. 3. Daily wear soft (hydrophilic) silicone hydrogel contact lenses, replaced on a monthly basis: Clariti Monthly and Air Optix Aqua. OptiFree Replenish was used as a care system by all subjects. 4. A total of 95 subjects were enrolled, and 94 subjects accounting for 188 eyes were dispensed lenses. This group was randomized into 64 test subjects (128 eyes)and 30 control subjects (60 eyes). 5. Of the 64 test subjects, 56 (87.5%) completed three months of use. Of the 30 control subjects, 29 (96.7%) completed three 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 three months of wear. Subjects were examined initially,and at five follow-up visits after one week, two weeks, four weeks, eight weeks and 12 weeks. Study visits commenced on September 6, 2010 and were completed on March 16, 2011. 1.3 Demographics Seven investigator sites dispensed 64 test subjects (128 eyes) who used Clariti Monthly as their contact lens during the work. Also enrolled were 30 control subjects (60 eyes)who used Air Optix Aqua as their contact lens during the work. All recruited subjects were existing contact lenses wearers. Of the 64 test subjects, 56 (87.5%) completed three months of use and eight (12.5%)were discontinued. Of the 30 control subjects, 29 (96.7%) completed three months of use and one (3.4%) was discontinued. The enrolled control group was made up of 22 females (73%) and eight males (27%) with an age range from 19 to 63 years (mean 35.6 years). The enrolled test group was composed of 41 females (63%) and 24 males (37%) with an age range from 17 to 62 years (mean 32.8 years). One ineligible subject (age 17 years) was enrolled and assigned to the test group but was not dispensed lenses.

Conditions

• Hyperopia
• Myopia

Interventions

Type	Name	Description
DEVICE	Air Optix Aqua	Lenses will be worn on a daily wear basis (ie. removed at night and stored in solution) and worn in the normal way. Lenses will be replaced each 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	Lenses will be worn on a daily wear basis (ie. removed at night and stored in solution) and worn in the normal way. Lenses will be replaced each 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: 2010-09-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2011-07-13
• Last updated: 2011-07-29

Locations

1 site across 1 country: United Kingdom