Dry Eye SyndromeNCT06190028
Evaluation of Performance and Safety of Carbopol 980 NF 0.2%- Based Medical Device in the Management of Patients With Glaucomar or Ocular Hypertension and Concomitant Dry Eye Syndrome on Multiple Long-term Topical Hypotensive Therapy
A study testing Iridium A Gel in people with Dry Eye Syndrome and Glaucoma and Concomitant Dry Eye Syndrome, run by Fidia Farmaceutici s.p.a. at 3 sites in Italy.
Trial summary
The main aim of this investigation is to evaluate the effect of the preservative-free ophthalmic solution IRIDIUM® A gel on the ocular surface of patients with glaucoma or OHT and concomitant DES under multiple long-term topical hypotensive therapy for at least 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome, Glaucoma and Concomitant Dry Eye Syndrome, Ocular Hypertension and Concomitant Dry Eye Syndrome
- What is being tested?
- Iridium A Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesItaly
- Study dates
- 14 Jun 2023to 10 Mar 2025
- Phase
- Interventional
- 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
- Have an age ≥ 18 years,;
- Have undergone the informed consent process and have signed an approved consent form;
- Are able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator's judgement;
- Have a diagnosis of glaucoma or Ocular Hypertension (OHT). Diagnosis of glaucoma will be based on: optic disc assessment, measurement of the retinal nerve fiber layer and neuroretinal rim with optical coherence tomography (OCT); characteristic repeatable visual field defects defined as a pattern standard deviation (PSD) with P < 0.05, and/or glaucoma hemifield test (GHT) results outside normal limits. Diagnosis of OHT will be based on history of IOP (intraocular pressure) > 21 mmHg in at least two occasions and normal optic disc and Humphrey visual field test;
- Are receiving an ongoing topical therapy with two or more preserved ocular hypotensive agents (e.g. beta-blockers, alpha-agonists, carbonic anydhrase inhibitors, prostaglandins) for at least 6 months and are willing to continue these treatments at unchanged dose for the entire investigation duration;
- Have a diagnosis of moderate to severe DES performed through the following exams: slit lamp examination (SLE), tear (lacrimal) meniscus exam, Schirmer's test, Tear Film Break-Up Time (TFBUT), fluorescein staining of the cornea and conjunctiva (Oxford Staining Scheme). Please note that a diagnosis of DES may be performed at entry in the investigation;
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- Have a Tear Film Break-Up Time (TFBUT) value < 7 sec;
- Have performed a Humphrey Visual Field Test in the last 4 months, if not available the test will be performed during the screening visit;
- In case of females of child-bearing potential (i.e., not permanently sterilized - post hysterectomy or tubal ligation status - or not postmenopausal), they must have a negative urine pregnancy test at T0 and use a reliable form of contraception for a least 1 month prior to T0 and throughout the investigation, according to the definition of Note 3 ofICH M3 Guideline*.
- Note: According to the definition of Note 3 of ICH M3 Guideline a highly effective method is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.
Who cannot join
- Best corrected visual acuity score < 20/40;
- Ischemic oculopathy;
- Contraindications to use of topical solution components used in this investigation or known allergy/hypersensitivity to any of the IRIDIUM®A gel ingredients;
- Current use/use in the past 15 days of any ocular medications other than hypotensive eye drops;
- Systemic treatments known to affect tear secretion;
- Treatment with any other therapy that, according to Investigator's judgment, could interfere with the assessment of the efficacy or incidence of adverse events;
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- Any history or slit lamp evidence of eye surface diseases different from DES;
- History of ocular trauma or surgery in the past 12 months;
- History of cataract in the past 6 months;
- Any history of corneal refractive surgery;
- Use of systemic steroids or immunosuppressants;
- Participation in another clinical study/investigation at the same time as the present investigation or within 30 days;
- History of drug, medication or alcohol abuse or addiction;
- Pregnant (positive urine pregnancy test) or breastfeeding women, or women planning to become pregnant during the investigation
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Policlinico San Martino
Genova, Genova, 16132
AOU Pisana Ospedale Cesanello
Pisa, Pisa, 56124
IRCCS Fondazione G.B. Bietti
Roma, Roma, 00183
About this study
Official title: Evaluation of Performance and Safety of IRIDIUM® A Gel Preservative-free Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension and Concomitant Dry Eye Syndrome on Multiple Long-term Topical Hypotensive Therapy: a Prospective, Multicentric, Open-label Clinical Investigation.
The main aim of this investigation is to evaluate the effect of the preservative-free ophthalmic solution IRIDIUM® A gel on the ocular surface of patients with glaucoma or OHT and concomitant DES under multiple long-term topical hypotensive therapy for at least 6 months. The underlying assumption is that ophthalmic solutions as adjuvants for the management of IOP- or glaucoma-associated dry eye may induce a protection of the eye surface with consequent improvement of the symptoms and of the overall quality of life.
Read the detailed description
IRIDIUM® A gel is a sterile, preservative free ophthalmic gel, containing Carbopol, amino acids, Echinacea and Aloe extract. IRIDIUM® A gel is indicated for the protection of the eye surface particularly at night, even in the presence of changes in histological continuity and blepharitic conditions, including those of an iatrogenic nature, following the use of hypotonic eye drops and of the preservatives contained therein.
The main component of IRIDIUM® A gel is the Carbomer Carbopol 980 NF, a water-soluble polyacrylic acid with good mucoadhesion. It gives the gel the chemical-physical properties of viscosity and elasticity necessary for proper lubrication of the eyelids, forming a stable fluid film on the outer eye it provides protection to the eye surface, particularly at night.
The first approach to treat patients with ocular surface diseases relies on the use of artificial tears. Tear substitutes increase the volume of fluid on the ocular surface, thus reducing cell damage. Indeed, they induce a decrease in the osmotic pressure of the tear film and of the friction caused by eyelid movements.
For this, aqueous gels formulated using hydrophilic polymers along with those based on stimuli responsive polymers (in situ gelling or gel forming systems) continue to attract increasing interest for various eye health-related applications. Among these, eye drops containing carbomers or sodium hyaluronate are increasingly being used because of their non-Newtonian time-dependent response to shear strain, resulting in a longer ocular residence time.
Dry eye can also occur following specific treatments. In this regard, has been reported that dry eye symptoms are more prevalent in patients with IOP and/or glaucoma using topical IOP-lowering medications compared to the general population.
The evidence from literature suggests that different topical anti-IOP/glaucoma medications have different levels of impact on the health of the ocular surface. The main driver for this observation is the presence of preservatives in topical IOP-lowering medications. Generally, preservative-free medications have fewer adverse effects compared with preserved medications. However, the presence of preservatives, such as benzalkonium chloride (BAK), in antihypertensive eye drops used for long term therapy can cause ocular discomfort symptoms in glaucoma patients. BAK reduces the stability of the tear film by acting as a detergent on the lipid layer, by reducing the number of mucin secreting goblet cells, thus altering mucin presence and distribution over the ocular surface epithelium.
Clinicians need to take proactive decisions to manage ocular surface diseases of glaucoma patients as they are serious, chronic conditions. Previous findings confirm that glaucoma patients have a higher need for the use of artificial tears than age-matched controls , emphasizing that patients with ocular surface disease secondary to the chronic use of antiglaucoma medications should be preferably treated with preservative-free artificial tears.
- Conditions
- Dry Eye Syndrome, Glaucoma and Concomitant Dry Eye Syndrome, Ocular Hypertension and Concomitant Dry Eye Syndrome, Multiple Long-term Topical Hypotensive Therapy
- Being tested
- Iridium A Gel
- Medical subject headings
- Dry Eye Syndromes, Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iridium A GelDevice
Also called Carbopol 0.2%
IRIDIUM® A gel is a sterile, preservative free ophthalmic gel, containing Carbopol, amino acids, Echinacea and Aloe extract. IRIDIUM® A gel is indicated for the protection of the eye surface particularly at night, even in the presence of changes in histological continuity and blepharitic conditions, including those of an iatrogenic nature, following the use of hypotonic eye drops and of the preservatives contained therein.
| Study group | Role | What they receive |
|---|---|---|
| IRIDIUM A gel | Experimental | Patients will receive IRIDIUM® A gel (four boxes to be used and one spare box) and they will be instructed to bilaterally apply 1 drop per eye onto the conjunctival sac 2 times a day for 60 days (one application during the day and one before going to sleep). Receives: Device: Iridium A Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Assessment of dry eye symptoms from baseline
Changes from baseline (T0) to Day 30 (T1) of the Impact of Dry Eye on Everyday Living (IDEEL) questionnaire ("Dry Eye Symptom-Bother" module) score following treatment with IRIDIUM® A gel. The "Dry Eye Symptom-Bother" module includes 20 items: Item 1 is scored on a 5-point Likert-like scale from 0 "none of the time" to 4 "all of the time"; Items 2-20 are scored on a 4-point Likert-like scale from 1 "not at all" to 4 "very much". Patients can also answer "I did not have this symptom / Not applicable" (scored 0).
Measured: Day 30
Efficacy Assessment of vision-related function from baseline
Dry Eye Symptom-Bother" module includes 20 items: Item 1 is scored on a 5-point Likert-like scale from 0 "none of the time" to 4 "all of the time"; Items 2-20 are scored on a 4-point Likert-like scale from 1 "not at all" to 4 "very much". Patients can also answer "I did not have this symptom / Not applicable" (scored 0)
Measured: Day 30
Secondary outcomes (9)
Efficacy Assessment of dry eye symptoms from baseline
Change from baseline of the IDEEL questionnaire ("Dry Eye Symptom-Bother" module) score.
The "Dry Eye Symptom-Bother" module includes 20 items: Item 1 is scored on a 5-point Likert-like scale from 0 "none of the time" to 4 "all of the time"; Items 2-20 are scored on a 4-point Likert-like scale from 1 "not at all" to 4 "very much". Patients can also answer "I did not have this symptom / Not applicable" (scored 0).
Measured: Day 60
Efficacy assement of tear film stability
Change from baseline (T0) to Day 30 (T1) and Day 60 (T2) of the Tear Film Break-Up Time (TFBUT).
This test is used to measure the tear film stability. Break-Up Time is defined as the time interval after a patient blink to the first appearance of dryness in the tear film. The patient is considered affected by dry eye if a dry area appears before 10 seconds
Measured: Day 30 and Day 60
Changes on Intraocular pressure from baseline
IOP measurement, using Goldmann applanation tonometry. Tonometry is the technique used to determine the intraocular pressure (IOP), the fluid pressure inside the eye. Normal eye pressure ranges from 10 to 21 mmHg. Goldmann applanation tonometer is currently the most widely used device in clinical practice for IOP measurements and is considered criterionstandard due to its low cost, lack of consumables, simplicity, and integration into the workflow of the slit lamp examination in a busy clinic.
Measured: Day 30 and Day 60
Assessment of patients' production of aqueous tears from baseline
Change from baseline the Schirmer's test I values. The Schirmer's test I is one of the commonly used methods to assess the aqueous tear production. A paper strip is inserted into the eye, under the eyelid, in the lower fornix near the lateral corner, away from the cornea, for five minutes to measure the production of tears. The wet portion of the strip is measured in millimeters. Values above 10 mm have to be considered normal
Measured: Day 30 and Day 60
Assessment of ocular surface health from baseline
Change from baseline of the quality of the cornea and the conjunctiva, as measured using the Oxford Staining Scheme. Staining with fluorescein will be used to identify corneal and conjunctival epithelium defects. Indeed, the corneal surface will stain whenever there is a disruption of cell-to-cell junctions. The staining can show corneal superficial punctate epithelial erosions in patterns that are consistent with certain causes of dry eye
Measured: Day 30 and Day 60
Assessment of conjunctival goblet cells (CGC) density and on the superficial corneal nerve fiber layer through confocal microscope
Confocal microscopy enables detailed investigation of tarsal and palpebral conjunctiva, central and peripheral cornea, tear film, and lids, and it allows evaluation of the ocular surface at the cellular level. The Heidelberg Retina Tomograph (HRT) is one of the well-established in vivo confocal imaging systems and, when combined with the "Rostock Cornea Module" (RCM), offers a new possibility for in vivo imaging histology for the visualization of the anterior segment of the eye.
The parameters will be analysed manually or using automated measurements with image analysis software. For the Cornea, density of epithelial cells (number of cells), endothelial morphology (percentage of normal cells), density of endothelial cells (number of cells) will be assessed.
Measured: Day 30 and Day 60
Assessment of conjunctival goblet cells (CGC) density and on the superficial corneal nerve fiber layer through confocal microscope
Confocal microscopy enables detailed investigation of tarsal and palpebral conjunctiva, central and peripheral cornea, tear film, and lids, and it allows evaluation of the ocular surface at the cellular level. The Heidelberg Retina Tomograph (HRT) is one of the well-established in vivo confocal imaging systems and, when combined with the "Rostock Cornea Module" (RCM), offers a new possibility for in vivo imaging histology for the visualization of the anterior segment of the eye.
The parameters will be analysed manually or using automated measurements with image analysis software. For the Conjunctiva, morphology (percentage of normal cells), density of cells (number of cells) muciparous caliciform (goblet) cells (number of cells) will be assessed.
Measured: Day 30 and Day 60
Assessment of conjunctival goblet cells (CGC) density and on the superficial corneal nerve fiber layer through confocal microscope
Confocal microscopy enables detailed investigation of tarsal and palpebral conjunctiva, central and peripheral cornea, tear film, and lids, and it allows evaluation of the ocular surface at the cellular level. The Heidelberg Retina Tomograph (HRT) is one of the well-established in vivo confocal imaging systems and, when combined with the "Rostock Cornea Module" (RCM), offers a new possibility for in vivo imaging histology for the visualization of the anterior segment of the eye.
The parameters will be analysed manually or using automated measurements with image analysis software. For the fibre layer, fibre layer: number of nervous fibres, cells form (entire or fragmented cells) will be assessed.
Measured: Day 30 and Day 60
Assessment of Incidence and nature of the Adverse Effects
Incidence and nature of the Serious Adverse Device Effects (SADEs); Incidence and nature of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs); Incidence and nature of the Adverse Device Effects (ADEs); Incidence and nature of Investigational Medical Device Deficiencies (IMDDs).
Measured: Day 30 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start14 Jun 2023
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Why it stopped: The investigation was prematurely interrupted with 65 patients enrolled due to difficulties in recruiting patients. However the results observed in the interim analysis demonstrate the performance of the investigational device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Iester, MD, Principal investigator, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190028
- Sponsor's protocol ID
- IS06-21-01
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance and Safety of IRIDIUM® A Gel Preservative-free Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension and Concomitant Dry Eye Syndrome on Multiple Long-term Topical Hypotensive Therapy: a Prospective, Multicentric, Open-label Clinical Investigation.
- ClinicalTrials.gov ID
- NCT06190028
- Acronym / sponsor ID
- IS06-21-01
- Conditions
- Dry Eye Syndrome, Glaucoma and Concomitant Dry Eye Syndrome, Ocular Hypertension and Concomitant Dry Eye Syndrome, Multiple Long-term Topical Hypotensive Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The investigation was prematurely interrupted with 65 patients enrolled due to difficulties in recruiting patients. However the results observed in the interim analysis demonstrate the performance of the investigational device.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this investigation is to evaluate the effect of the preservative-free ophthalmic solution IRIDIUM® A gel on the ocular surface of patients with glaucoma or OHT and concomitant DES under multiple long-term topical hypotensive therapy for at least 6 months. The underlying assumption is that ophthalmic solutions as adjuvants for the management of IOP- or glaucoma-associated dry eye may induce a protection of the eye surface with consequent improvement of the symptoms and of the overall quality of life.
Detailed description
IRIDIUM® A gel is a sterile, preservative free ophthalmic gel, containing Carbopol, amino acids, Echinacea and Aloe extract. IRIDIUM® A gel is indicated for the protection of the eye surface particularly at night, even in the presence of changes in histological continuity and blepharitic conditions, including those of an iatrogenic nature, following the use of hypotonic eye drops and of the preservatives contained therein.
The main component of IRIDIUM® A gel is the Carbomer Carbopol 980 NF, a water-soluble polyacrylic acid with good mucoadhesion. It gives the gel the chemical-physical properties of viscosity and elasticity necessary for proper lubrication of the eyelids, forming a stable fluid film on the outer eye it provides protection to the eye surface, particularly at night.
The first approach to treat patients with ocular surface diseases relies on the use of artificial tears. Tear substitutes increase the volume of fluid on the ocular surface, thus reducing cell damage. Indeed, they induce a decrease in the osmotic pressure of the tear film and of the friction caused by eyelid movements.
For this, aqueous gels formulated using hydrophilic polymers along with those based on stimuli responsive polymers (in situ gelling or gel forming systems) continue to attract increasing interest for various eye health-related applications. Among these, eye drops containing carbomers or sodium hyaluronate are increasingly being used because of their non-Newtonian time-dependent response to shear strain, resulting in a longer ocular residence time.
Dry eye can also occur following specific treatments. In this regard, has been reported that dry eye symptoms are more prevalent in patients with IOP and/or glaucoma using topical IOP-lowering medications compared to the general population.
The evidence from literature suggests that different topical anti-IOP/glaucoma medications have different levels of impact on the health of the ocular surface. The main driver for this observation is the presence of preservatives in topical IOP-lowering medications. Generally, preservative-free medications have fewer adverse effects compared with preserved medications. However, the presence of preservatives, such as benzalkonium chloride (BAK), in antihypertensive eye drops used for long term therapy can cause ocular discomfort symptoms in glaucoma patients. BAK reduces the stability of the tear film by acting as a detergent on the lipid layer, by reducing the number of mucin secreting goblet cells, thus altering mucin presence and distribution over the ocular surface epithelium.
Clinicians need to take proactive decisions to manage ocular surface diseases of glaucoma patients as they are serious, chronic conditions. Previous findings confirm that glaucoma patients have a higher need for the use of artificial tears than age-matched controls , emphasizing that patients with ocular surface disease secondary to the chronic use of antiglaucoma medications should be preferably treated with preservative-free artificial tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRIDIUM A gel | Experimental | Device: Iridium A GelPatients will receive IRIDIUM® A gel (four boxes to be used and one spare box) and they will be instructed to bilaterally apply 1 drop per eye onto the conjunctival sac 2 times a day for 60 days (one application during the day and one before going to sleep). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have an age ≥ 18 years,;
- Have undergone the informed consent process and have signed an approved consent form;
- Are able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator's judgement;
- Have a diagnosis of glaucoma or Ocular Hypertension (OHT). Diagnosis of glaucoma will be based on: optic disc assessment, measurement of the retinal nerve fiber layer and neuroretinal rim with optical coherence tomography (OCT); characteristic repeatable visual field defects defined as a pattern standard deviation (PSD) with P < 0.05, and/or glaucoma hemifield test (GHT) results outside normal limits. Diagnosis of OHT will be based on history of IOP (intraocular pressure) > 21 mmHg in at least two occasions and normal optic disc and Humphrey visual field test;
- Are receiving an ongoing topical therapy with two or more preserved ocular hypotensive agents (e.g. beta-blockers, alpha-agonists, carbonic anydhrase inhibitors, prostaglandins) for at least 6 months and are willing to continue these treatments at unchanged dose for the entire investigation duration;
Key exclusion criteria (14 listed)
- Best corrected visual acuity score < 20/40;
- Ischemic oculopathy;
- Contraindications to use of topical solution components used in this investigation or known allergy/hypersensitivity to any of the IRIDIUM®A gel ingredients;
- Current use/use in the past 15 days of any ocular medications other than hypotensive eye drops;
- Systemic treatments known to affect tear secretion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iridium A GelAlso: Carbopol 0.2%IRIDIUM® A gel is a sterile, preservative free ophthalmic gel, containing Carbopol, amino acids, Echinacea and Aloe extract. IRIDIUM® A gel is indicated for the protection of the eye surface particularly at night, even in the presence of changes in histological continuity and blepharitic conditions, including those of an iatrogenic nature, following the use of hypotonic eye drops and of the preservatives contained therein. | Device | IRIDIUM A gel |
Primary outcome
Efficacy Assessment of dry eye symptoms from baseline
Time frame: Day 30
Changes from baseline (T0) to Day 30 (T1) of the Impact of Dry Eye on Everyday Living (IDEEL) questionnaire ("Dry Eye Symptom-Bother" module) score following treatment with IRIDIUM® A gel. The "Dry Eye Symptom-Bother" module includes 20 items: Item 1 is scored on a 5-point Likert-like scale from 0 "none of the time" to 4 "all of the time"; Items 2-20 are scored on a 4-point Likert-like scale from 1 "not at all" to 4 "very much". Patients can also answer "I did not have this symptom / Not applicable" (scored 0).
Efficacy Assessment of vision-related function from baseline
Time frame: Day 30
Dry Eye Symptom-Bother" module includes 20 items: Item 1 is scored on a 5-point Likert-like scale from 0 "none of the time" to 4 "all of the time"; Items 2-20 are scored on a 4-point Likert-like scale from 1 "not at all" to 4 "very much". Patients can also answer "I did not have this symptom / Not applicable" (scored 0)
9 secondary outcomes
Efficacy Assessment of dry eye symptoms from baseline
Time frame: Day 60
Efficacy assement of tear film stability
Time frame: Day 30 and Day 60
Changes on Intraocular pressure from baseline
Time frame: Day 30 and Day 60
Assessment of patients' production of aqueous tears from baseline
Time frame: Day 30 and Day 60
Assessment of ocular surface health from baseline
Time frame: Day 30 and Day 60
Assessment of conjunctival goblet cells (CGC) density and on the superficial corneal nerve fiber layer through confocal microscope
Time frame: Day 30 and Day 60
Assessment of conjunctival goblet cells (CGC) density and on the superficial corneal nerve fiber layer through confocal microscope
Time frame: Day 30 and Day 60
Assessment of conjunctival goblet cells (CGC) density and on the superficial corneal nerve fiber layer through confocal microscope
Time frame: Day 30 and Day 60
Assessment of Incidence and nature of the Adverse Effects
Time frame: Day 30 and Day 60
Results and safety
The study was stopped early (reason given: The investigation was prematurely interrupted with 65 patients enrolled due to difficulties in recruiting patients. However the results observed in the interim analysis demonstrate the performance of the investigational device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Iester, MD principal investigator
Ospedale Policlinico San Martino
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iridium A Gel in people with Dry Eye Syndrome and Glaucoma and Concomitant Dry Eye Syndrome, run by Fidia Farmaceutici s.p.a. at 3 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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The investigation was prematurely interrupted with 65 patients enrolled due to difficulties in recruiting patients. However the results observed in the interim analysis demonstrate the performance of the investigational device.). Results are not available in the source record.
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?
Efficacy Assessment of dry eye symptoms from baseline (time frame: Day 30). 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?
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 25 Feb 2026.