Contact lens lubricant for rigid gas-permeable (OK) lens wearers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, randomized, open-label, positive parallel-controlled trial enrolling about 152 rigid gas-permeable corneal (OK) contact lens wearers. Participants are randomly assigned to treatment groups and provided with lenses, lubricants, and care solutions as specified by the protocol. Clinical follow-up visits are scheduled at 1 week, 1 month, and 3 months after starting use to monitor safety and outcomes. Primary efficacy indexes include the percentage of patients with binocular comfort score ≥ Level 3 at 1 month and the percentage with maintained best-corrected distance visual acuity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 8 and older, no gender limitation;
2. Rigid gas permeable corneal contact lens (OK lens) wearers;
3. The best corrected distance visual acuity of framed lenses in both eyes can reach 5.0 (5-Point Scale);
4. Be able and willing to comply with all treatments and follow-ups;
5. Be able to understand the purpose of the trial, participate voluntarily and have ICF signed by the subject himself/herself or his/her legal guardian.

Exclusion Criteria:

1. Patients with only one eye meeting the inclusion criteria.
2. Patients with abnormal clinical abnormalities or systemic diseases affecting the eyes that occurred or is occurring before screening and, in the investigator's judgment, preclude the use of corneal contact lenses.
3. Patients with some eye diseases that affect contact lens wearing: such as acute or chronic eye diseases, conjunctivitis catarrhalis aestiva, glaucoma, corneal abnormalities, keratoconus, etc.
4. Patients with allergies to the components of contact lens or contact lens care solution involved in this trial;
5. Patients who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature (e.g. immunosuppressant, glucocorticoids, IOP-lowering drugs, low concentration atropine) during the study;
6. Patients with a history of intraocular operation;
7. Patients with abnormal IOP (the single eye IOP \<10 mmHg or \>21mmHg, or the IOP difference of both eyes \>5mmHg), obvious fundus abnormalities, examination of corneal endothelial cell (abnormal ≥ Level 4), or slit-lamp examination abnormalities.
8. Patients with dry eye syndrome or with break up time (BUT) \<5s.
9. Subjects who participated in other drug clinical trials within 90 days before screening, and participated in other medical device clinical trials within 30 days;
10. Patients who wore rigid contact lens (including orthokeratology lens) within the past 30 days;
11. Patients who are pregnant, nursing or planning to conceive at the enrollment;
12. Patients with contraindications for wearing rigid contact lenses or unsuitable for wearing rigid contact lenses as indicated by examination results;
13. Other conditions for which the investigator judged the patient unsuitable for inclusion.

Where it's running

• Beijing Aier Intech Eye Hospital
  Beijing, Beijing Municipality, China Recruiting
• Tianjin Eye Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Tianjin Medical University Eye Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Yanhong Li
• Email: lyh@cisema.com.cn
• Phone: +86(0)1060356258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.