Phase 2 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to understand the study and sign and date a consent form
• People who are between 18 and 75 years old at the time of giving consent
• People who have been diagnosed with Sjögren's syndrome (SS) for at least 3 months before joining the study
• People who have been using only artificial tears (no other eye drops or treatments) for their dry eye for at least 30 days before the first visit
• People who have been on a stable dose of any systemic (whole-body) medications for at least one month before the first visit
• People whose dry eye symptoms score at least 40 on a specific symptom questionnaire called the Global SANDE scale
• People whose average pain and discomfort scores for typical dry eye symptoms (such as dryness, burning, itching, blurred vision, and light sensitivity) meet a specific minimum level on a rating scale
• People whose eye surface staining results fall within a specific mild-to-moderate range in both eyes (confirm with trial site)
• People who are willing to follow all study procedures, attend all scheduled visits, and stay in the study for its full duration
• People who are able to apply the study medication themselves and are willing to follow the medication schedule

Who may not be able to join:

• People who have, or have a history of, an eye or whole-body condition other than dry eye that the investigator believes could affect the study results — examples include eye infections, certain types of conjunctivitis, corneal conditions, uveitis, or active systemic infections

• People who have used any prescription or therapeutic eye drops (such as cyclosporine or steroid drops), certain eye treatment devices, or had eye surgery in the 30 days before the first visit

• People who are not willing to avoid using other eye treatments, medical devices, or having eye surgery from the first visit through to the fourth visit

• People who have only one eye

• People who are not willing to use the study's vehicle (inactive) eye drops three times a day during the run-in period

• People who are not willing to limit their use of artificial tears to no more than 4 days during the run-in period

• People who have recently started regularly taking systemic supplements or medications for Sjögren's syndrome or related dry eye — such as fish oil, steroids, or immune-suppressing drugs — within the month before the first visit, if the investigator believes this could affect results

• People who are not willing to keep their systemic medication routine stable for the whole duration of the study

• People who have a known allergy or sensitivity to any ingredient in the study medications or procedures

• People who are currently in another clinical trial or have been in one within the 30 days before the first visit

• People who have a history of drug, medication, or alcohol misuse or addiction

• Women who could become pregnant and who are currently pregnant, had a positive pregnancy test at screening, plan to become pregnant during the study or within 30 days after it ends, are breastfeeding, or are not willing to use highly effective contraception (such as hormonal or barrier methods) throughout the study and for 30 days after it ends

• Men whose female partner could become pregnant, where the man has not had a surgical sterilisation procedure, where information about the partner's pregnancy status is not available, or where the female partner does not meet the pregnancy-related criteria above

• People who have a history of a serious physical or psychiatric condition that, in the investigator's opinion, could prevent them from following study procedures or taking part safely

• People with any other medical or surgical condition that the investigator believes could affect their safety or ability to participate

Important: Always verify eligibility with the trial site directly before applying.