Clinical trial NCT01996787: Clinical Study of Visibility Tinted Clariti Contact Lens
Official title: The Clinical Performance of the Clariti Contact Lens (Including Handling Tint) for Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Myopia
Keywords: visibility tinted silicone hydrogel contact lenses for daily wear
Lead sponsor: Sauflon Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Slit lamp Biomicroscopy
timeFrame: 1 month
measure: Adverse reactions
timeFrame: 1 month
measure: Wear Time
timeFrame: 1 month
measure: Visual Acuity
timeFrame: 1 month
Secondary outcomes:
measure: Subjective Scores
timeFrame: 1 month
measure: Symptoms, problems and complaints
timeFrame: 1 month
measure: Discontinuations
timeFrame: 1 month
measure: Refraction
timeFrame: 1 month
measure: Keratometry
timeFrame: 1 month
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research Faculty of Life Sciences The University of Manchester
Study officials:
affiliation: MCOptom FAAO FBCLA
name: Philip Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varikooty J, Keir N, Richter D, Jones LW, Woods C, Fonn D. Comfort response of three silicone hydrogel daily disposable contact lenses. Optom Vis Sci. 2013 Sep;90(9):945-53. doi: 10.1097/OPX.0b013e31829d8dbf.
citation: Belda-Salmeron L, Ferrer-Blasco T, Albarran-Diego C, Madrid-Costa D, Montes-Mico R. Diurnal variations in visual performance for disposable contact lenses. Optom Vis Sci. 2013 Jul;90(7):682-90. doi: 10.1097/OPX.0b013e318299088f.
citation: Montes-Mico R, Belda-Salmeron L, Ferrer-Blasco T, Albarran-Diego C, Garcia-Lazaro S. On-eye optical quality of daily disposable contact lenses for different wearing times. Ophthalmic Physiol Opt. 2013 Sep;33(5):581-91. doi: 10.1111/opo.12044. Epub 2013 Mar 19.