Ocutec daily disposable contact lens comfort evaluatio

Completed

• Conditions: Myopia and hyperopia; Eye Diseases

• Registration Number: ISRCTN25271353
• Lead Sponsor: Ocutec Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-04
• Study Completion: 2016-01-07
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Be at least 18 years old and full legal capacity to volunteer
2. Read, understand and sign written statement of informed consent
3. Appears able and willing to follow instructions and maintain the appointment schedule
4. Existing soft contact lens wearer (at least 4 weeks daily wear prior to study)
5. Require a visual correction in both eyes (monovision allowed but no monofit)
6. Have a spherical contact lens requirement in the range of -1.00 to -4.00 DS
7. Have no greater than 1.00 DS difference in contact lens spherical requirements between eyes
8. Have astigmatism <1.25DC in both eyes
9. Monocular distance visual acuity correctable to 6/9 (20/40) or better in each eye best sphero-cylindrical refraction
10. Have normal eyes with no evidence of any ocular abnormality or disease. For the purpose of the study a normal eye is defined as having one of these:
10.1. Clear central cornea
10.2. No anterior segment disorder
10.3. No clinically significant slit lamp findings (corneal oedema, staining, central scarring, infiltrates, active neovascularisation)
10.4. No other active ocular disease or recent surgery

Exclusion Criteria

1. Any systematic disease affecting ocular health
2. Any systemic or topical medications that will in the investigators opinion affect ocular physiology or contact lens performance
3. Have severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of the contact lenses
4. Has persistent, clinically significant corneal or conjuctival staining using fluorescein dye (> Grade 3)
5. Is aphakic
6. Has undergone corneal refractive surgery
7. Is participating in any other type of eye-related clinical or research study
8. Pregnancy, lactating or planning a pregnancy at the time of enrolment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Overall comfort at the 8 hour visit<br>2. High contrast visual acuity with over-refraction at the 8 hour visit<br>3. Non-invasive break up time at the 8 hour visit<br>4. Lens wettability at the 8 hour visit<br>5. Overall fit acceptance at the 8 hour visit<br><br>All the outcome measure will be assesses using standard optometry equipment and metrology and patient interviews and observation.

Secondary Outcome Measures

Name	Time	Method
1. Bulbar hyperaemia at the 8 hour visit<br>2. Corneal staining at the 8 hour visit<br><br>All the outcome measure will be assesses using standard optometry equipment and metrology and patient interviews and observation.