Surface Coated Hydrophilic Contact Lenses to control bacterial contamination during continuous wear modality

Phase 2

Completed

• Conditions: Health Condition 1: - Health Condition 2: null- PATIENTS REQUIRING REFRACTIVE ERROR CORRECTIO

• Registration Number: CTRI/2015/10/006327
• Lead Sponsor: Hyderabad Eye Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-08-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 208

Inclusion Criteria

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.

Exclusion Criteria

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, Sjögrens 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified