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Dry Eye DiseasePhase 1NCT06375343

Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®

A Phase 1 study testing PRO-240 and Optive® in people with Dry Eye Disease and Dry Eye Sensation, run by Laboratorios Sophia S.A de C.V..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
PRO-240 and Optive®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
30 Jan 2026to 30 Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older 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 ≥18 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 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

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Alejandra Sanchez-Rios, MD contact

33 3001 4200

alejandra.sanchez@sophia.com.mx

About this study

Official title: Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-240 Ophthalmic Solution Compared to Optive® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers

This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.

Read the detailed description

The variables to be evaluated include:

Primary (safety):

  • Incidence of unexpected advere events (AE's)

Secondary:

  • Changes in the ocular comfort index (OCI) score
  • Changes in intraocular pressure (IOP)
  • Changes in Best Corrected Visual Acuity (BCVA)
  • Adherence to treatment
  • Changes in tear film breakup time
  • Changes in fluorescein staining
  • Changes in lissamine green staining
Being tested
PRO-240, Optive®
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-240Drug

    -Propylene glycol 0.3%, Polyethylene glycol 400 0.5%, and Glycerin 0.2%. Ophthalmic solution.

  • Optive®Drug

    • Carboxymethylcellulose 0.5%, and Glycerin 0.9%. Ophthalmic solution.
Study groups in NCT06375343
Study groupRoleWhat they receive
PRO-240Experimental* Propylene glycol 0.3% - Polyethylene glycol 400 0.5% - Glycerin 0.2%. Ophthalmic solution. * Dosage: 1 drop QID [4] (four times per day) for 7 days in both eyes. * Route of administration: Ophthalmic
Receives: Drug: PRO-240
Optive®Active comparator* Carboxymethylcellulose 0.5%; Glycerin 0.9%. Ophthalmic solution. * Dosage: 1 drop QID [4] (four times per day) for 7 days in both eyes. * Route of administration: Ophthalmic
Receives: Drug: Optive®

What is being measured

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

  1. Incidence of unexpected adverse events related to the interventions

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

    Measured: Days 0: (Basal Visit), 8 (Final Visit) and 11 (Safety Call)

Secondary outcomes (7)

  1. Changes in the Ocular Comfort Index score

    Changes in the Ocular Comfort Index (OCI) score in between interventions, the subjects will be questioned regarding this symptoms' incidence. The OCI contains 8 items (one positive and eight negative) that focus on discomfort associated with ocular surface disorders. Each of these questions has two parts, which separately inquire about the frequency and severity of symptoms.

    The OCI score will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.

    Measured: Days: 0 (Basal Visit), and 8 (Final Visit)

  2. Adherence to treatment (adherence) Adherence to treatment (adherence)

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

    Measured: Days: 8 (Final Visit)

  3. Changes in Best Corrected Visual Acuity (BCVA)

    The BCVA will be evaluated through Snellen chart.

    Measured: Days: 0 (Basal Visit) and 8 (Final Visit)

  4. Changes in tear film breakup time

    The most common method for assessing stability is with fluorescein. The precorneal layer colored with fluorescein will change to less fluorescent or non-fluorescent regions. The time from the last blink to the appearance of these regions is the tear film breakup time.

    Measured: Days: 0 (Basal Visit) and 8 (Final Visit)

  5. Changes in intraocular pressure (IOP)

    Previous instillation of topical anesthetic, the IOP will be measured through a Goldmann tonometer during visits

    Measured: Days: 0 (Basal Visit) and 8 (Final Visit)

  6. Changes in the integrity of the ocular surface (fluorescein staining)

    Changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E.

    Measured: Days: 0 (Basal Visit) and 8 (Final Visit)

  7. Changes in lissamine green staining of the conjunctival surface

    Direct observation with slit lamp, graded according to (changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance [SICCA].)

    Measured: Days: 0 (Basal Visit) and 8 (Final Visit)

Timeline

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

  1. First posted19 Apr 2024
  2. Study start30 Jan 2026 (estimated)
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Jan 2027 (estimated)

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, single-blind, single-center, comparative clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06375343
Sponsor's protocol ID
SOPH240-0923/I
Status last verified
Mar 2025
First submitted
12 Apr 2024
Last updated
19 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-240 and Optive® in people with Dry Eye Disease and Dry Eye Sensation, run by Laboratorios Sophia S.A de C.V..

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: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Alejandra Sanchez-Rios, MD (33 3001 4200, alejandra.sanchez@sophia.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of unexpected adverse events related to the interventions (time frame: Days 0: (Basal Visit), 8 (Final Visit) and 11 (Safety Call)). 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 NCT06375343.

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 19 Mar 2025.

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