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Dry Eye DiseasePhase 1NCT06370585

Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF

A Phase 1 study testing PRO-229 and Lagricel® Ofteno PF in people with Dry Eye Disease and Ocular Surface Disease, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Dry Eye Disease, Ocular Surface Disease
What is being tested?
PRO-229 and Lagricel® Ofteno PF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteMexico
Study dates
16 May 2024to 13 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Having the ability to voluntarily give their signed informed consent.
  • Ophthalmologically and clinically healthy subjects.
  • Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
  • Age between 18 to 45 years.
  • Male or female gender.
  • Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
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  • Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
  • Corneal staining ≤ grade I on the Oxford Scale.
  • Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.

Who cannot join

  • History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or any of the components of the drugs under investigation.
  • Use of ophthalmic medications from any pharmacological group.
  • Use of medications by any other route of administration.
  • Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.
  • History of eye surgery in the last 6 months.
  • Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
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  • In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
  • Having participated in any clinical research study 30 days prior to inclusion in this study.
  • Having previously participated in this same study.
  • History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.
  • Diagnosis of glaucoma or ocular hypertension.
  • Known diagnosis of liver or heart disease.
  • Presenting active inflammatory or infectious disease at the time of entry into the study.
  • Presenting unresolved lesions or traumas at the time of entry into the study.
  • Having been subjected to non-ophthalmological surgical procedures in the last 3 months.
  • Being or having an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an employee of the research site or the sponsor, and who directly participates in this study.
  • Active smoking (specified as the consumption of cigarettes regardless of the amount and frequency, 4 weeks prior to study inclusion and during the intervention period of this study).
  • Active alcoholism (specified as the consumption of alcoholic beverages, regardless of the amount and frequency, 72 hours prior to study inclusion and during the intervention period of this study).
  • Elimination Criteria
  • Withdrawal of their consent to participate in the study (informed consent form).
  • Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.
  • Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).
  • Non-tolerability or hypersensitivity to any of the drugs under investigation.
  • Adherence < 80% determined by the subject's diary and corroborated by the final weight of the research products (RP) compared to the initial weight.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Asociacion Mexicana para la Investigacion Clinica

    Pachuca, Hidalgo, 42070

Other trials in Mexico

About this study

Official title: Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF in Clinically Healthy Subjects

This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects.

Read the detailed description

The variables to be evaluated include:

Primary objective:

  • To evaluate the safety and tolerability of PRO-229 ophthalmic solution compared to Lagricel® Ofteno PF in clinically healthy subjects.

Specific objective:

  • To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF through the incidence of adverse events related to both investigational products.

Secondary Objectives:

  • To compare the safety of vs. PRO-229 formulation compared to Lagricel® Ofteno PF by changes in Best Corrected Visual Acuity (BCVA).
  • To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF by changes in ocular surface staining assessed with the the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale.
  • To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF by the incidence of chemosis.
  • To compare the tolerability of PRO-229 formulation compared to Lagricel® Ofteno PF by changes in conjunctival hyperemia grades 3 or 4.
  • To ompare the tolerability of PRO-229 formulation compared to Lagricel® Ofteno Ophthalmic PF by adherence to treatment.
Being tested
PRO-229, Lagricel® Ofteno PF
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO-229Drug

    • Dexpanthenol 2% and sodium hyaluronate 0.15% ophthalmic solution.

  • Lagricel® Ofteno PFDrug

    • Sodium hyaluronate 0.4%. Ophthalmic solution.
Study groups in NCT06370585
Study groupRoleWhat they receive
PRO-229Experimental* Dexpanthenol 2% and sodium hyaluronate 0.15% ophthalmic solution. * Dosage:1 drop QID [4] (four times per day) for 7 days on right both eyes. * Route of administration: Ophthalmic. * Presentation: Multidose dropper bottle.
Receives: Drug: PRO-229
Lagricel® Ofteno PFActive comparator* Sodium hyaluronate 0.4%. Ophthalmic solution. * Dosage: 1 drop QID [4] (four times per day) for 7 days on right both eyes. * Route of administration: Ophthalmic. * Presentation: Multidose dropper bottle.
Receives: Drug: Lagricel® Ofteno PF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Unexpected Related Adverse Reactions

    Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.

    Measured: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.

Secondary outcomes (5)

  1. Changes in Best Corrected Visual Acuity (BCVA)

    BCVA will be evaluated through Snellen chart

    Measured: Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.

  2. Changes in ocular surface staining using SICCA ocular staining score scale

    Changes in ocular surface staining will be evaluated using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects.

    Measured: Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.

  3. Incidence of chemosis

    Incidence of chemosis will be evaluated through direct observation by principal investigator

    0 = Absent

    1 = Present

    Measured: Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.

  4. Incidence of grade 3 or 4 conjunctival hyperemia.

    Conjunctival hyperemia will be evaluated through Efron grading scale.

    Measured: Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.

  5. Adherence to treatment (adherence)

    Adherence will be evaluated through the treatment record in the subject's diary.

    Measured: Through an average of 8 days. This evaluations will take place on days 8 (Final Visit) after the inclusion of each subject.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start16 May 2024
  3. Primary completion25 Jul 2024
  4. Study completion13 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase I, controlled, comparative, double-masked, single-center, randomized, controlled clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06370585
Sponsor's protocol ID
SOPH229-0823/I
Status last verified
Mar 2025
First submitted
10 Apr 2024
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRO-229 and Lagricel® Ofteno PF in people with Dry Eye Disease and Ocular Surface Disease, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Unexpected Related Adverse Reactions (time frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06370585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.

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