Clinical Study of Clariti Monthly Contact Lens

NCT01392950 | Completed

• 1 other identifier: S10-491
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperopia; Myopia

Keywords

silicone hydrogel contact lenses for daily wear

Outcome Measures

Primary Outcomes (1)

• Overall subjective acceptance

  The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon CLARITI (somofilcon A) Soft Silicone Hydrogel Contact Lens with UV Blocker to the predicate device for its intended use.

  3 months

Study Arms (2)

Air Optix Aqua

ACTIVE COMPARATOR

Compare safety and efficacy using OptiFree Replenish solution

Device: Air Optix Aqua

Clariti

ACTIVE COMPARATOR

Compare safety and efficacy of the lens using OptiFree Replenish solution

Device: Clariti

Interventions

Air Optix Aqua DEVICE

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.

Air Optix Aqua

Clariti DEVICE

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.

Clariti

Eligibility Criteria

• Age: 19 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will only be eligible for the study if:
• 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.
• They agree not to participate in other clinical research for the duration of this study.
• They can attain at least 6/9 in each eye with the study contact lenses.
• 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.

You may not qualify if:

• Subjects will not be eligible if:
• They have an ocular disorder which would normally contra-indicate contact lens wear.
• They have a systemic disorder which would normally contra-indicate contact lens wear.
• They are using any topical medication such as eye drops or ointment.
• They have glaucoma (high pressure in the eye), have had cataract surgery or a history of recurring abrasions.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• They are pregnant or lactating.
• They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
• They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Sponsors & Collaborators

• Sauflon Pharmaceuticals Ltd: lead

Study Sites (1)

Eurolens Research Faculty of Life Sciences The University of Manchester

Manchester, Manchester, M60 1QD, United Kingdom

Location

MeSH Terms

Conditions

Hyperopia; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Philip Morgan, PhD

  MCOptom FAAO FBCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 13, 2011
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2011
• Last Updated: July 29, 2011

Record last verified: 2011-07

Locations

GB (1)