Evaluating the comfort, vision and fit of soft, spherical contact lenses in nearsighted and farsighted individuals.

Not Applicable

• Conditions: earsightedness and farsightedness.; Eye Diseases; Myopia and hyperopia

• Registration Number: ISRCTN28339062
• Lead Sponsor: Ocutec Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-18
• Last Update Posted: 29 July 2019
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. =18 years old
2. Willing to wear supplied over-spectacle correction if required
3. Existing soft contact lens wearers (at least 4 weeks daily wear prior to study).
4. Require a visual correction in both eyes (monovision allowed but no monofit).
5. Have a spherical contact lens requirement in the range of -1.00D to -4.00D.
6. Have no greater than 1.00D difference in contact lens spherical requirement between eyes.
7. Have astigmatism <1.25D in both eyes.
8. Monocular distance visual acuity correctable to 6/9 (20/30) or better in each eye with sphero-cylindrical refraction.
9. Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:
9.1. Clear central corneas
9.2. No anterior segment disorder
9.3. No clinically significant slit lamp findings (i.e. corneal oedema, staining, central scarring, infiltrates, active neovascularisation)
9.4. No other active ocular disease or recent surgery

Exclusion Criteria

1. Any systemic disease affecting ocular health
2. Any systemic or topical medications that will in the investigator’s opinion affect ocular physiology or contact lens performance
3. Severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
4. Persistent, clinically significant corneal or conjunctival staining using fluorescein dye (= Grade 3)
5. Aphakic
6. Undergone corneal refractive surgery
7. Participating in any other type of eye related clinical or research study
8. Pregnancy, lactating or planning a pregnancy at the time of enrollment
9. Participation in any trial within the last 14 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Comfort is assessed by the subject is assessed by the subject at 30 minutes and 8 hours<br> 2. High contrast VA is measured using computer-generated logMAR charts at 30 minutes and 8 hours<br> 3. Non-invasive break-up time is measured using the Keeler Tearscope® and grid at 30 minutes and 8 hours<br> 4. Pre-lens tear film quality is measured by slit lamp examination at 30 minutes and 8 hours<br> 5. Overall lens fit is measured by slit lamp examination after at 30 minutes and 8 hours<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Bulbar hyperaemia (0-4) is measured by Slit Lamp examination at 30 minutes and 8 hours or at another time if the subject is discontinued from the study early<br> 2. Corneal staining (0-4) is measured by Slit Lamp examination at 8 hours or at another time if the subject is discontinued from the study early<br>