Clinical Study of Clariti Monthly Contact Lens

Myopia Clinical Trial

Official title: Clinical Performance of the Clariti Monthly Contact Lens for Daily Wear

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyperopia
• Myopia

• NCT number: NCT01392950
• Study type: Interventional
• Source: Sauflon Pharmaceuticals Ltd
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Completion date: March 2011