A prospective, contralateral lens wear, randomised, controlled, 2-arm, 3-months clinical trial to test the efficacy and safety of two surface modified contact lenses during continuous wear modality.

Hyderabad Eye Research Foundation0 个研究点目标入组 208 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
•2. Be at least 18 years old, male or female.
•3. Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
•4. Have ocular health findings considered to be â??normalâ?? and which would not prevent the participant from safely wearing contact lenses.
•5. Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses/spectacles.
•6.Be experienced or inexperienced at wearing contact lenses.
•7. Require contact lens correction between -0.75 and -6.00 D.

•1. Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
•2. Any systemic disease that adversely affects ocular health e.g. diabetes, Gravesâ??s disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, SjÃ¶grens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
•3. An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
•4. Use of or a need for any therapeutic ocular medication at enrolment (and would be discontinued during the study);
•5. Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participantâ??s ocular health/physiology or contact lens performance either in an adverse manner or risk providing a false positive.
•6. Eye surgery within 12 weeks immediately prior to enrolment for this trial.
•7. Previous corneal refractive surgery.
•8. Known allergy or intolerance to ingredients in any of the study products.
•9. Currently enrolled in another clinical trial or participation in a clinical trial within the previous 2 weeks.
•10. Pregnancy (Testing of pregnancy is not required. A participantâ??s verbal report is sufficient).

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