An interventional study of PRGF and Balanced Salt Solution (BSS®) in Dry Eye Disease With Severe Keratitis, sponsored by Gladys Lucia Silva Linares. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Gladys Lucia Silva Linares · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate the change in dry eye symptoms after the treatment with Plasma Rich in Growth Factors (PRGF) in patients with severe dry eye. The main question it aims to answer is:
Are dry eye simptoms less after the treatment with PRGF?
Researchers will compare standard topical treatment and PRGF with standard topical treatment and placebo to see if there is a difference in dry eye symptoms between arms. Secondary outcomes include changes in tear meniscus height, non invasive tear break-up time, conjunctival hyperemia, meibomian gland dropout and Ocular Staining Score (OSS) scale for corneal and conjunctival damage.
Participants will be asked to use standard treatment and PRGF or placebo for 1 month.
Dry eye disease is a multifactorial condition that significantly affects patients' quality of life and, in many cases, shows a limited response to conventional topical treatment. PRGF has demonstrated anti-inflammatory and regenerative properties on the ocular surface, with favorable clinical outcomes in previous studies conducted primarily in foreign populations. However, there is limited evidence in Latin American populations, which justifies conducting this study.
A prospective, randomized, masked study will be conducted, including 100 patients over 18 years of age with a diagnosis of severe dry eye disease. Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. The control group will receive standard topical treatment, including eyelid hygiene, artificial tears, cyclosporine, topical corticosteroids with a tapering regimen, and balanced saline solution as a placebo. The intervention group will receive the same standard treatment, with topical PRGF replacing the placebo, administered four times daily for a period of one month.
All patients will be evaluated at a baseline visit and at a follow-up visit four weeks after treatment initiation. All patients will receive a follow-up telephone call two weeks after treatment initiation, and follow-up of each patient after completion of the study will be conducted according to the treating physician's judgment. The primary objective of the study is to determine the change in dry eye symptoms using the Ocular Surface Disease Index 6 (OSDI-6) questionnaire. Secondary objectives will include evaluation of changes in clinical signs of the ocular surface, including tear quantity and stability, conjunctival hyperemia, Meibomian gland dysfunction, corneal and conjunctival staining, as well as the occurrence of treatment-related adverse events.
In both groups, the treating physician may add medications to the standard treatment at their discretion, as well as other therapies such as punctal plugs. Other non-invasive therapies, such as intense pulsed light, low-level light therapy, quantum molecular resonance, thermal pulsation therapy, or laser/plasma technology, may not be performed while the patient is participating in the study.
The risks associated with the study are considered minimal and are primarily related to the blood draw required for PRGF preparation and the topical use of the product, which may result in mild and transient local adverse events.
The study will be conducted in accordance with the principles of the Declaration of Helsinki, the Good Clinical Practice Guidelines, and Ministerial Agreement 206-2021 of the Ministry of Public Health and Social Assistance of Guatemala. All participants will provide written informed consent prior to enrollment in the study. The confidentiality of personal data will be ensured through the coding of information, and the study will have civil liability insurance covering any harm directly resulting from participation in the research.
1,367 studies on the registry are indexed under Dry Eye Syndromes; 208 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Gladys Lucia Silva Linares as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard topical treatment will include: eyelid hygiene once daily with a preservative-free foaming solution; preservative-free 3% sodium hyaluronate eye drops as needed; preservative-free 0.05% cyclosporine twice daily; loteprednol 0.2% twice daily for 15 days, followed by once daily for 7 days; polyacrylic acid 0.2% as needed.
Other: PRGF
Standard topical treatment will include: eyelid hygiene once daily with a preservative-free foaming solution; preservative-free 3% sodium hyaluronate eye drops as needed; preservative-free 0.05% cyclosporine twice daily; loteprednol 0.2% twice daily for 15 days, followed by once daily for 7 days; polyacrylic acid 0.2% as needed.
Other: Balanced Salt Solution (BSS®)
PRGF eyedrops four times a day for 1 month
Balanced salt solution 0.09% eyedrops four times a day for 1 month
Dry eye symptoms
Difference in Ocular Surface Disease Index - 6 (OSDI-6) questionnaire, scale is from 0 to 24. Higher scores mean worst symptoms
Time frame: 4 weeks
Tear meniscus height
Difference in tear film quantity measured in milimiters
Time frame: 4 weeks
Non invasive tear break-up time (NiBUT)
Difference in tear break-up meassured in seconds
Time frame: 4 weeks
Conjunctival hyperemia score (ocular redness)
Difference in conjunctival hyperemia score. Scale is 0-4. Lower scores mean less inflammation
Time frame: 4 weeks
Meibomian gland drop-out (meibography)
Difference in meibomian gland drop-out. Scale is 0-3. Higher score indicate more severe structural loss of the meibomian glands
Time frame: 4 weeks
Ocular Straining Score (OSS) scale
Difference in corneal and conjunctival damage. Scale is 0-12. Higher value correlates with grater severity of the disease
Time frame: 4 weeks
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — According to local law we are unable to share individual participant data
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 12 months is close to that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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