Influences of Viscosity of Lubricating Eye Drops on Orthokeratology Treatment Outcomes

Phase 3

• Conditions: Anterior Eye Health; Refractive Error; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12619000773134
• Lead Sponsor: Ms Kuan-Li Lily Ho

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-24
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

At least 18 years of age
- Have worn the same pair of orthokeratology lenses regularly for at least 1 month
- Good understanding of and ability to communicate using the English language
- Willing to comply with use of ocular lubricants involved and visit schedule
- No known allergy to ocular lubricants

Exclusion Criteria

- Currently under the treatment of any eye disease (whether that be anterior or posterior eye involvement) except refractive error corrections
- Use of oral or topical medications that may alter eye findings
- Any previous ocular injuries, eye conditions or eye surgeries
- Has worn soft contact lenses in the past week

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with a change in corneal staining by 1 grade according to CCLRU scale.[1. Baseline result 1 (taken prior to commencement of treatment)<br>2. Result 1 (after 1 week of treatment) (primary endpoint)<br>3. Baseline result 2 (after wash-out period prior to commencement of cross-over)<br>4. Result 2 (after 1 week of treatment) (primary endpoint)];Proportion of participants with a change in subjective comfort measured by a visual analogue scale in the follow-up questionnaire designed specifically for the study.[1. Baseline result 1 (taken prior to commencement of treatment)<br>2. Result 1 (after 1 week of treatment) (primary endpoint)<br>3. Baseline result 2 (after wash-out period prior to commencement of cross-over)<br>4. Result 2 (after 1 week of treatment) (primary endpoint)]

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with a change in refractive error of at least 0.25D measured by manual phoropter refraction and auto-refraction.[1. Baseline result 1 (taken prior to commencement of treatment)<br>2. Result 1 (after 1 week of treatment) (secondary endpoint)<br>3. Baseline result 2 (after wash-out period prior to commencement of cross-over)<br>4. Result 2 (after 1 week of treatment) (secondary endpoint)];Proportion of participants with a change in visual acuity by 0.02 (per letter) measured by LogMAR chart.[1. Baseline result 1 (taken prior to commencement of treatment)<br>2. Result 1 (after 1 week of treatment) (secondary endpoint)<br>3. Baseline result 2 (after wash-out period prior to commencement of cross-over)<br>4. Result 2 (after 1 week of treatment) (secondary endpoint)]