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New eye gel shows promise for dry eye sufferers

NCT ID NCT03697876

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

Aug 2018

Finished

Jun 2024

Lead sponsor

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Leslie victoria Aguilar Saldaña

    Mexico City, Mexico City, 07020, Mexico

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Other studies related to the condition(s) this trial covers.