Evaluating the comfort, vision and fit of Ocutec daily disposable contact lenses in comparison with Acuvue OASYS contact lenses.

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: Participants are given contact lenses to wear contralaterally for 8 hours. Participants are instructed to wear either a Ocutec PEG spherical soft lenses in one eye and a control soft contact lens Acuvue OASYS® in the other eye. The eye to which each lens is worn is assigned randomly. A random number generator (Microsoft Excel) determines the randomisation of lenses to subjects, which is then incorporated into the Randomisation Log. ID numbers (a six‐digit code, made up of the study identifier (PG), the two‐digit subject enrolment number and the initial letters of their first and last names) is assigned consecutively to maintain randomisation. Visit 1: Participants are assessed at baseline and receive standard contact lens care (eye examination and measurements). Participants are then given the contact lens to wear and they insert them in their eyes. Lenses are allowed to settle for a minimum of 10 minutes prior for initial assessment of fit, comfort and for vision. Participants have two follow up visits during the study. After the lens fit the subjects remain in the clinic until the 30 minutes post insertion for their first follow up. After 30 minutes of wear, participants are assessed for comfort, lens preference, vision, lens surface and lens fit. Participants must show acceptable lens fit with both lenses and must be corrected to 0.20 logMAR (6/9) or better for binocular distance VA (over‐spectacle correction may be used if required). If the lenses do not display suitable fitting, or the subject is unable to achieve 0.20 logMAR or better distance VA then they are discontinued from the study and an Exit form is completed. The Participant Instruction Guide is provided to all subjects which contains instructions regarding lens wear. The Investigator or a clinical assistant reviews instructions and warnings for lens wear and other important issues with the participant. Participants who appear unable or unwilling to follow instruction CONDITION: Nearsightedness and farsightedness ; Eye Diseases ; Myopia and hyperopia PRIMARY OUTCOME: ; 1. Comfort is assessed by the subject is assessed by the subject at 30 minutes and 8 hours; 2. High contrast VA is measured using computer‐generated logMAR charts at 30 minutes and 8 hours; 3. Non‐invasive break‐up time is measured using the Keeler Tearscope® and grid at 30 minutes and 8 hours; 4. Pre‐lens tear film quality is measured by slit lamp examination at 30 minutes and 8 hours; 5. Overall lens fit is measured by slit lamp examination after at 30 minutes and 8 hours; SECONDARY OUTCOME: ; 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; 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; INCLUSION CRITERIA: 1. =18 years old 2. Willing to wear supplied over‐spectacle correction if required 3. Be 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 best 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: 9.1. Having clear central corneas 9.2. No anterior s
Epistemonikos ID: 46479dfd14144cc69dfb12557847a80030fd8b1c
First added on: Aug 24, 2024