Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solutio… (NCT04704531) | Clinical Trial Compass
CompletedPhase 2
Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease.
Mexico141 participantsStarted 2022-01-03
Plain-language summary
Phase II, comparative, controlled, multicenter, parallel group, open, randomized clinical study. The main outcome variable will be the Ocular Surface Disease Index (OSDI) questionnaire. Three dosage schemes of topical ophthalmic application of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%; preservative free) are to be evaluated in patients diagnosed with mild to severe dry eye. Each group will be exposed to one of the following administration schemes: 1 drop bis in die (BID), 1 drop quater in die (QID), or 1 drop six times per day; instillation will take place in both eyes (OU).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years old.
* Being capable of voluntarily grant a signed informed consent.
* Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
* Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.
* Presenting a mild to moderate dry eye disease diagnosis, defined as:
* OSDI score between 13 and 32, plus one of the following:
* More than 5 dots of corneal staining
* More than 9 dots of conjunctival staining
* Tear Break-up Time (BUT) \< 10 seconds
Exclusion Criteria:
* Pregnancy, breastfeeding or planning to become pregnant during the time of the study
* Having participated in clinical trials within 30 days prior to signing this study's informed consent form.
* Having participated previously in this study.
* Best Corrected Visual Acuity (BCVA) equal or worse than 20/200, in either eye.
* Diagnosis of any of the following:
* Allergic, viral or bacterial conjunctivitis
* Anterior blepharitis
* Parasite infestation of ocular structures (Demodex, for example)
* Unresolved history of ocular trauma
* Scarring diseases of the ocular surface
* Corneal or conjunctival ulcers
* Filamentary keratitis
* Neurotrophic keratitis
* Bullous keratopathy
* Neoplastic diseases of the ocular surface or ocular annexes
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Ocular Surface Disease Index (OSDI)
Timeframe: Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).