| NCT ID | NCT07796178 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Eye Research Associates, LLC |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-09-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-09-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 years of age. * Have the potential of 20/40 visual acuity or better post-cataract surgery. * have cataract surgery scheduled for both eyes * Corneal staining score of ≥3 on the original National Eye Institute (NEI; 0-15 total score) staining scale in the study eye. * willing to discontinue contact lens throughout the study? * pre-treatment OSDI scores of ≤12 (asymptomatic)? Exclusion Criteria: * Known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)? * History of ocular surgery within the past 12 months (excluding cataract surgery) * Anticipated complications from cataract surgery in either eye? * History of severe ocular trauma, active ocular infection or inflammation that is not dry eye-related? * Used Accutane or is currently using ocular medications/treatments outside of study treatments? Artificial tears will be allowed. * Physical meibomian gland treatment withing 1 month of enrollment? * Having any conditions or are in a situation, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study. * Currently pregnant or breast feeding
Frequently Asked Questions
Who can join the NCT07796178 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dry Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07796178 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07796178 currently recruiting?
Yes, NCT07796178 is actively recruiting participants. Visit ClinicalTrials.gov or contact Eye Research Associates, LLC to inquire about joining.
Where is the NCT07796178 trial being conducted?
This trial is being conducted at Pittsburg, United States, Kansas City, United States.
Who is sponsoring the NCT07796178 clinical trial?
NCT07796178 is sponsored by Eye Research Associates, LLC. The trial plans to enroll 40 participants.