New eye gel shows promise for dry eye sufferers
NCT ID NCT03697876
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new eye gel called PRO-165 to see if it is safe and tolerable for people with dry eyes. 32 healthy adults used either the new gel or a standard lubricating gel. The goal was to check for side effects and comfort, not to cure dry eye.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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32 people
The number who actually took part.
- Started
-
Aug 2018
- Finished
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Jun 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent. * Systemically and ophthalmologically healthy subjects evaluated during the clinical history. * Age between 18 to 45 years. * Both genders. * Blood tests (complete blood count, three element blood chemistry and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%) * Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute) * Visual capacity 20/30 or better, in both eyes. * Intraocular pressure ≥11 and ≤ 21 mmHg. Exclusion Criteria: * Subjects with a history of hypersensitivity to any of the components of the research products. * Subject users of topical ophthalmic medications of any pharmacological group. * Subject users of medication by any other route of administration. * Women who are pregnant or lactating. * Women without a history of bilateral tubal obstruction, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period. * Subjects with participation in clinical research studies 90 days prior to inclusion in the present study. * Known diagnosis of liver disease * Inability to attend or answer the evaluations made in each of the visits. * Positive tobacco use (specified as cigarette consumption regardless of quantity and frequency) * Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period). * Contact lens users. Medical and therapeutic exclusion criteria. * History of any chronic-degenerative disease. * Inflammatory or infectious disease, active at the time of study entry. * Injuries or traumatisms not resolved at the time of entry into the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Leslie victoria Aguilar Saldaña
Mexico City, Mexico City, 07020, Mexico
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Other studies related to the condition(s) this trial covers.
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