BridgeMD
Tests treatment safety and results for Myopia
Official title Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers
ClinicalTrials.gov ID: NCT07091825
What this study is testing
- What it's testing
- This trial aims to evaluate the safety and effectiveness of LACRIFRESH OCU-DRY 0.3% OSD, a contact lens lubricant produced by AVIZOR, S.A. This clinical trial adopts a Multi-center, randomized, open-label, positive parallel-controlled design in accordance with the principles outlined in the Norms on the Quality Management for the Clinical Trials of Medical Devices issued by the National Medical Products Administration of China.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- Aged 8 and older, no gender limitation;
- Rigid gas permeable corneal contact lens (OK lens) wearers;
- The best corrected distance visual acuity of framed lenses in both eyes can reach 5.0 (5-Point Scale);
- Be able and willing to comply with all treatments and follow-ups;
- 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.
You likely can't join if
- Patients with only one eye meeting the inclusion criteria.
- Patients with abnormal clinical abnormalities or systemic diseases affecting the eyes that occurred or is occurring before screening and, in the...
- Patients with some eye diseases that affect contact lens wearing: such as acute or chronic eye diseases, conjunctivitis catarrhalis aestiva...
- Patients with allergies to the components of contact lens or contact lens care solution involved in this trial;
- Patients who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature (e.g. immunosuppressant, glucocorticoids...
- Patients with a history of intraocular operation;
See the full eligibility criteria
- Aged 8 and older, no gender limitation;
- Rigid gas permeable corneal contact lens (OK lens) wearers;
- The best corrected distance visual acuity of framed lenses in both eyes can reach 5.0 (5-Point Scale);
- Be able and willing to comply with all treatments and follow-ups;
- 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.
- Patients with only one eye meeting the inclusion criteria.
- 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.
- 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.
- Patients with allergies to the components of contact lens or contact lens care solution involved in this trial;
- 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;
- Patients with a history of intraocular operation;
- Patients with abnormal IOP (the single eye IOP \ 21mmHg, or the IOP difference of both eyes \>5mmHg), obvious fundus abnormalities, examination of corneal endothelial cell (abnormal ≥ Level 4), or slit-lamp examination...
- Patients with dry eye syndrome or with break up time (BUT) \<5s.
- people who participated in other drug clinical trials within 90 days before screening, and participated in other medical device clinical trials within 30 days;
- Patients who wore rigid contact lens (including orthokeratology lens) within the past 30 days;
- Patients who are pregnant, nursing or planning to conceive at the enrollment;
- Patients with contraindications for wearing rigid contact lenses or unsuitable for wearing rigid contact lenses as indicated by examination results;
- Other conditions for which the investigator judged the patient unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.