A clinical trial to evaluate the Safety and Efficacy of Pro-ocular™ topical gel in two different concentration, 0.5% and 1%, when administered in the forehead twice a day for 12 weeks in Patients diagnosed with Dry Eye Syndrome.

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 - ProGIFT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000747-27-IT

Enrollment

105

Registered

2020-10-07

Start date

2020-09-09

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms, in which tear film instability, hyperosmolarity, ocular surface inflammation and damage, neurosensory abnormalities play an etiological role. Patient-reported symptoms for DE include dryness, grittiness, itching, redness, fluctuating visual disturbances and ocular fatigue. MedDRA version: 21.1 Level: LLT Classification code 10013777 Term: Dry eye

Interventions

Product Name: Pro-ocular Product Code: [Pro-ocular] Pharmaceutical Form: Gel INN or Proposed INN: PROGESTERONE CAS Number: 57-83-0 Current Sponsor code: NA Concentration unit: µg microgram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients (male or female) must be >= 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 == 1 and =65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: - Comorbidity with other severe or chronic eye 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 - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the efficacy of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients with moderate to severe dry eye syndrome.;Secondary Objective: The secondary objectives of this study are to further evaluate the efficacy of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome. The secondary objectives also include the safety of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.;Primary end point(s): - Mean change from baseline (Visit 1 pre-dose) in fluorescein corneal staining assessed by NEI scale at Week 12 (Day 84) - 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);Timepoint(s) of evaluation of this end point: 84 days	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the efficacy of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients with moderate to severe dry eye syndrome.;Secondary Objective: The secondary objectives of this study are to further evaluate the efficacy of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome. The secondary objectives also include the safety of progesterone topical gel (0.5% and 1%) compared to placebo gel, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.;Primary end point(s): - Mean change from baseline (Visit 1 pre-dose) in fluorescein corneal staining assessed by NEI scale at Week 12 (Day 84) - 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);Timepoint(s) of evaluation of this end point: 84 days

—

Secondary

Measure	Time frame
Secondary end point(s): - Mean change from baseline (Visit 1 pre-dose) in corneal staining assessed by NEI scale at Week 12 (Day 84).; Mean change from baseline (Visit 1 pre-dose) in TearScan grading at each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; Mean change from baseline (Visit 0 Screening) in Schirmer Test at Week 4 (Day 28) and at Week 12 (Day 84).; 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)].; Impact of dry eye on quality of life by using Dry Eye-Related Quality-of-Life questionnaire (DEQS).; Absolute score of each symptom item in Visual Analogue Scale to each post baseline visit.; Mean change from baseline (Visit 1 pre-dose) in Corneal Sensitivity to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; 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)].; 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)].; 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.; Mean change from baseline (Visit 1 pre-dose) in Fluorescein Tear Film Break UP (TBUT) at Week 12 (Day 84).; 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)].; 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.; 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	—

Measure

Time frame

Secondary end point(s): - Mean change from baseline (Visit 1 pre-dose) in corneal staining assessed by NEI scale at Week 12 (Day 84).; Mean change from baseline (Visit 1 pre-dose) in TearScan grading at each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; Mean change from baseline (Visit 0 Screening) in Schirmer Test at Week 4 (Day 28) and at Week 12 (Day 84).; 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)].; Impact of dry eye on quality of life by using Dry Eye-Related Quality-of-Life questionnaire (DEQS).; Absolute score of each symptom item in Visual Analogue Scale to each post baseline visit.; Mean change from baseline (Visit 1 pre-dose) in Corneal Sensitivity to each applicable post-baseline visit [Week 2, 4, 8, 12 (Day 14, 28, 56, 84)].; 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)].; 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)].; 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.; Mean change from baseline (Visit 1 pre-dose) in Fluorescein Tear Film Break UP (TBUT) at Week 12 (Day 84).; 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)].; 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.; 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

—

Countries

Italy

Contacts

Public ContactANNA RITA BLANCO

SOCIETA' INDUSTRIA FARMACEUTICA ITALIANA (SIFI) s.p.a

rita.blanco@sifigroup.com0957922201

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026