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Dry Eye DiseasePhase 2ProGIFTNCT04645446

Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome

A Phase 2 study testing Pro-ocular gel in people with Dry Eye Disease, run by SIFI SpA at 4 sites in Italy.

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

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 clinical trial. The study objective is to evaluate the safety and efficacy of two different concentrations (0.5% and 1%) of progesterone topical gel compared to placebo, when administered twice a day for 3 months (12 weeks) in patients… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
Pro-ocular gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
4 sitesItaly
Study dates
18 Feb 2021to 27 Oct 2022
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients (male or female) ≥ 18 years of age.
  • Able and willing to provide voluntary written Informed Consent prior to any study related procedure.
  • Patients must be diagnosed with any type of dry eye at least 3 months before screening (Visit 0).
  • Have all the following in the same eye at Visit 0:
  • Fluorescein staining (Cornea) on NEI (National Eye Institute) grading scale > 3
  • Average Tear Film Break up Time ≤ 5 seconds
  • Schirmer Test (without anesthesia) ≥ 1 and < 10mm
  • Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator.

Who cannot join

  • Comorbidity with other severe or chronic conditions that in the judgment of the investigator will interfere with study assessment, such as such as glaucoma, active neuronal trigeminal disease, neuralgia.
  • Best corrected visual acuity (BCVA) baseline <20/200.
  • Condition or history other than ocular that, in the opinion of the investigator, may interfere significantly with the patient's participation in the study, such as dementia, psychosis, Parkinson's disease (interference).
  • Patient using a contact ocular lens within 7 days prior to administration of the first dose and not willing to cease using them during all study duration.
  • Female patients who are pregnant, nursing an infant, or planning a pregnancy or lactating at Screening Visit.
  • Females who are of childbearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable non-hormonal contraceptive precautions can be included (See Note A).
Show all 18Show fewer
  • Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study.
  • A known adverse reaction and/or sensitivity to the study drug or its components.
  • Use of topical ocular cyclosporine, corticosteroids or any other topical anti-inflammatory treatments within 15 days prior to Visit 0 and during all study duration.
  • Routine use (more than twice a week) of a chlorinated swimming pool during the study period
  • Unwilling or unable to cease using during the study period the forbidden medications:
  • Any topical ocular ointments or gels
  • Topical and systemic glaucoma therapies
  • Systemic drugs with anticholinergic activity: anticonvulsants, antihistamines, antipsychotics, antidepressants, antimuscarinics, anti-Parkinson agents, cardiovascular agents (disopyramide), gastrointestinal agents, muscle relaxants, respiratory medications (pseudoephedrine, theophylline)
  • Lipidic artificial tears and artificial tears with preservative.
  • Unwilling to cease the use of sunscreen on the forehead or eye area during the study period.
  • Habitual cigarette smokers (tobacco, vapor cigarettes, marijuana), smoking more than 4 cigarettes per day.
  • Participation in another clinical study at the same time as the present and within 30 days prior to Visit 0.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Ospedale San Marco - Azienda Ospedaliera Universitaria

    Catania, 95121,

  • A.O.U. Careggi Firenze - SOD Oculistica

    Florence, 50134

  • Azienda Ospedaliera Universitaria Policlinico G. Martino - UOC di Oftalmologia

    Messina, 98125

  • Ospedale Luigi Sacco Polo Universitario - Oculistica

    Milan, 20157

Other trials in Italy

About this study

Official title: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Pro-ocular™ 0.5% and 1% in Patients With Dry Eye Syndrome

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 clinical trial.

The study objective is to evaluate the safety and efficacy of two different concentrations (0.5% and 1%) of progesterone topical gel compared to placebo, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.

Conditions
Dry Eye Disease
Being tested
Pro-ocular gel, Placebo gel
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-ocular gelDrug

    Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

  • Placebo gelDrug

    Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

Study groups in NCT04645446
Study groupRoleWhat they receive
Pro-ocular™ 1% Progesterone EP topical gelExperimentalMultidose formulation despensing unit doses of 0.07 g of topical gel containing 0.7 mg of progesterone
Receives: Drug: Pro-ocular gel
Pro-ocular™ 0.5% Progesterone EP topical gelExperimentalMultidose formulation despensing unit doses of 0.07 g of topical gel containing 0.35 mg of progesterone
Receives: Drug: Pro-ocular gel
Placebo topical gelPlacebo comparatorMultidose formulation identical in appearance to Experimental Products despensing unit doses of 0.07 g of topical gel containing 0 mg of progesterone
Receives: Drug: Placebo gel

What is being measured

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

  1. Corneal Fluorescein Staining

    Mean change from baseline (Visit 1 pre-dose) in corneal fluorescein staining assessed by NEI scale at Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)

    Measured: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)

  2. SANDE questionnaire

    Mean change from baseline (Visit 1 pre-dose) in sum of frequency and intensity of dryness/irritation patient feeling assessed by SANDE questionnaire at Week 12 (Day 84) (with LOCF imputation)

    Measured: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)

Secondary outcomes (16)

  1. Corneal fluorescein staining

    Mean change from baseline (Visit 1 pre-dose) in corneal fluorescein staining assessed by NEI scale at Week 12 (Day 84).

    Measured: Week 12 (Day 84)

  2. SANDE questionnaire

    Mean change from baseline (Visit 1 pre-dose) in sum of frequency and intensity of dryness/irritation patient feeling assessed by SANDE questionnaire at Week 12 (Day 84).

    Measured: Week 12 (Day 84)

  3. Conjunctival fluorescein staining

    Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 12 (Day 84) (with LOCF imputation).

    Measured: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)

  4. Conjunctival fluorescein staining

    Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 12 (Day 84).

    Measured: Week 12 (Day 84)

  5. Corneal fluorescein staining

    Mean change from baseline (Visit 1 pre-dose) in corneal fluorescein staining assessed by NEI scale at Week 2, 4, 8 (Day 14, 28, 56) as intermediate study visits.

    Measured: Week 2, 4, 8 (Day 14, 28, 56)

  6. SANDE questionnaire

    Mean change from baseline (Visit 1 pre-dose) in sum of frequency and intensity of dryness/irritation patient feeling assessed by SANDE questionnaire at Week 2, 4, 8, 16 (Day 14, 28, 56,114) as intermediate study visits.

    Measured: Week 2, 4, 8, 16 (Day 14, 28, 56,114)

  7. Conjunctival fluorescein staining

    Mean change from baseline (Visit 1 pre-dose) in conjunctival fluorescein staining assessed by NEI scale at Week 2, 4, 8 (Day 14, 28, 56) as intermediate study visits.

    Measured: Week 2, 4, 8 (Day 14, 28, 56)

  8. Non-Invasive Keratograph Tear Film Break Up (NIKBUT) Time (NIKBUT)

    Mean change from baseline (Visit 1 pre-dose) in Non-Invasive Keratograph Tear Film Break Up Time (NIKBUT) at each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].

    Measured: Week 2, 4, 8, 12 (Day 14, 28, 56, 84)

  9. Fluorescein Tear Film Break Up Time (TBUT)

    Mean change from baseline (Visit 1 pre-dose) in Fluorescein Tear Film Break Up Time (TBUT) at Week 12 (Day 84).

    Measured: Week 12 (Day 84)

  10. Tear meniscus height (TMH)

    Mean change from baseline (Visit 1 pre-dose) in Tear meniscus height (TMH) at each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].

    Measured: Week 2, 4, 8, 12 (Day 14, 28, 56, 84)]

  11. Schirmer test

    Mean change from baseline (Visit 0 Screening) in Schirmer test at Week 4 (Day 28) and at Week 12 (Day 84).

    Measured: Week 4 (Day 28) and Week 12 (Day 84)

  12. Dry Eye-Related Quality-of-Life (DEQS) questionnaire

    Impact of dry eye on quality of life by using Dry Eye-Related Quality-of-Life (DEQS) questionnaire.

    Measured: Each applicable post baseline visit

  13. Visual Analogue Scale

    Absolute score of each symptom item in Visual Analogue Scale to each post baseline visit.

    Measured: Each applicable post baseline visit

  14. Visual Analogue Scale

    Mean change from baseline (Visit 1 pre-dose) in Visual Analogue Scale 7 symptoms items to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].

    Measured: Week 2, 4, 8, 12 (Day 14, 28, 56, 84)

  15. Corneal Sensitivity

    Mean change from baseline (Visit 1 pre-dose) in Corneal Sensitivity to each applicable postbaseline visit [Week 4, 12 (Day 28, 84)].

    Measured: Week 4, 12 (Day 28, 84)

  16. Slit Lamp Examination

    Mean change from baseline (Visit 0 Screening) in Slit Lamp Examination to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].

    Measured: Week 2, 4, 8, 12 (Day 14, 28, 56, 84)

Timeline

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

  1. First posted27 Nov 2020
  2. Study start18 Feb 2021
  3. Primary completion27 Oct 2022
  4. Study completion27 Oct 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Allocation Ratio = 1:1:1
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04645446
Sponsor's protocol ID
049/SI
Other IDs
2019-000747-27, 2019
Acronym
ProGIFT
Status last verified
Mar 2021
First submitted
25 Nov 2020
Last updated
23 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pro-ocular gel in people with Dry Eye Disease, run by SIFI SpA at 4 sites in Italy.

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 8 inclusion and 18 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 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Corneal Fluorescein Staining (time frame: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)). The study lists 2 primary outcomes in all. 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 NCT04645446.

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 23 Dec 2022.

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