Contact Lens Performance Novel Endpoints Validation

• Research type

  Research Study

• Full title

  Contact Lens Performance Novel Endpoints Validation

• IRAS ID

  335090

• Sponsor organisation

  Ocular Technology Group-International

• Duration of Study in the UK

  0 years, 6 months, days

• Research summary

  Research Summary

  In clinical practice the level of vision is measured by reading black letters on a white background but this does not represent the vision needs in everyday life when the contrast is most of the time not 100%. In clinical research we need to precisely measure vision under the range of conditions that represent people vision needs in everyday life. Contact lens comfort and vision depend upon many factors with an important one being how well the tear film wets the surface of the contact lens.

  Two novel methods, one to test vision using targets of different contrasts and the other to measure the coverage of the contact lens by the tear film have been developed. The objective of the study is to determine how reliable are the methods.

  The study will involve three visits, the first visit will be to enroll the participants and familiarise them with the tests. The other two visits will follow the same routine, the participants will be fitted with the same contact lens type at the two visits, their contrast vision will be measured and the tear film at the front of the contact lens video recorded for analysis after the visit. The results obtained at the two visits will be compared to determine the reliability of the methods.

  Summary of Results

  The objective of the study was to determine the repeatability of pre contact lens tear film kinetics by measuring the break area over 30 seconds post eye opening and the repeatability of vision contrast detection by measuring timed Landolt ring contrast threshold at four spatial frequencies. The study which involved carrying the measurements on two separate occasions on the same participants demonstrated that the methods were clinically repeatable and estimated the sample sizes that would be required to detect clinically relevant differences between contact lens types.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  23/WM/0232

• Date of REC Opinion

  1 Nov 2023

• REC opinion

  Further Information Favourable Opinion