Clinical Study of Visibility Tinted Clariti Contact Lens
- Conditions
- HyperopiaMyopia
- Interventions
- Device: Air Optix AquaDevice: Clariti with Handling Tint
- Registration Number
- NCT01996787
- Lead Sponsor
- Sauflon Pharmaceuticals Ltd
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- They are 18 years of age and above
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent
- They are willing and able to follow the protocol
- The agree not to paticipate in other clinical research for the duration of this study
- They have a best spectacle corrected visual acuity greater or equal to 20/25 (logMAR 0.1)
- They have a manifest cylinder less than or equal to 0.75D
- They have successfully worn contact lenses within six months of starting the study
- They can be fitted with spherical soft contact lenses within the power range available
- They are willing to wear the study lenses for a minimum of four days a week, six hours a day
- They have any active anterior segment ocular disease which would normally contraindicate contact lens wear
- They have any anterior segment infection, inflammation or abnormality
- They use any systemic medications which would normally contraindicate contact lens wear
- They are using any ocular medications
- They have a history of herpetic keratitis
- They have a systemic disorder which would normally contraindicate contact lens wear
- They have any infectious disease (e.g. Hepatitis) or any immunosuppressive disease (e.g. HIV)
- They have glaucoma (high pressure in the eye), have had cataract surgery or a history of recurring abrasions
- They have had corneal refractive surgery or they have an irregular cornea
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus
- They are pregnant or lactating
- They have any slit lamp findings which are more serious than grade 1
- They have a history of anaphylaxis or severe allergic reactions
- They have taken part in any other contact lens or contact lens care product clinical trial or research, within two weeks prior to starting this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Air Optix Aqua Air Optix Aqua Compare safety and efficacy of the lens using OptiFree Replenish solution Clariti with Handling Tint Clariti with Handling Tint Compare safety and efficacy of the lens using OptiFree Replenish solution Clariti with Handling Tint Air Optix Aqua Compare safety and efficacy of the lens using OptiFree Replenish solution Air Optix Aqua Clariti with Handling Tint Compare safety and efficacy of the lens using OptiFree Replenish solution
- Primary Outcome Measures
Name Time Method Slit lamp Biomicroscopy 1 month 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).
Wear Time 1 month Lens wear time is recorded for the two study lenses at follow-up visits.
Adverse reactions 1 month Adverse reactions will be recorded throughout the study. Adverse recations will be classified as serious, significant and non-significant.
Visual Acuity 1 month 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.
- Secondary Outcome Measures
Name Time Method Subjective Scores 1 month 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.
Symptoms, problems and complaints 1 month The presence or absence of symptoms, problems and complaints will be recorded at two-weeks and one-month visits.
Discontinuations 1 month All subjects discontinuations will be recorded at the two-week and one-month visits.
Refraction 1 month Refraction was undertaken and recorded for all subjects at the initial, two-weeks and one-month visits.
Keratometry 1 month Keratometry measures will be performed at the initial and one-month visits for all subjects.
Trial Locations
- Locations (1)
Eurolens Research Faculty of Life Sciences The University of Manchester
🇬🇧Manchester, United Kingdom