Ocular Surface DiseaseNCT04536129
Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure
A study testing Hydrocortisone (CORTIVIS ®) in people with Ocular Surface Disease and Glaucoma, run by University of Molise at 1 site in Italy.
Trial summary
Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD (ocular surface disease) patients with and without glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease, Glaucoma
- What is being tested?
- Hydrocortisone (CORTIVIS ®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2019to 4 Mar 2020
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age of at least 18 years
- diagnosis of OSD (Ocular Surface Disease)
- normal ophthalmic findings except history of OSD for at least 3 months, and current therapy with topical lubricants for at least 3 months
- POAG (primary open-angle glaucoma ) patients on medical therapy
Who cannot join
- clinically significant slit lamp findings at screening visit except OSD
- participation in a clinical trial in the 4 weeks preceding the screening visit
- symptoms of a clinically relevant illness in the 3 weeks before the screening visit
- presence/ history of a severe medical or surgical condition
- intake of parasympathomimetic or antipsychotic drugs
- wearing of contact lenses
Show all 17Show fewer
- previous refractive laser surgery (e.g photorefractive keratectomy-PRK, laser assisted in situ keratomileusis-LASIK, etc.)
- history of IOP increase caused by systemic or topical treatment with corticosteroids
- IOP greater than 22 mmHg
- treatment with corticosteroids in the 4 weeks preceding the study
- types of glaucoma other than POAG
- ocular infection or clinically significant inflammation
- ocular surgery in the 3 months preceding the study
- Sjögren's syndrome, Stevens-Johnson syndrome
- history of allergic conjunctivitis
- pregnancy, planned pregnancy or lactating
- known hypersensitivity to any component of study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure in Patients With and Without Glaucoma
Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD (ocular surface disease) patients with and without glaucoma.
Read the detailed description
The ocular surface comprises the cornea, conjunctiva, eyelids and lacrimal glands and any disorder in these structures can be classified as an ocular surface disorder (OSD). OSD includes Dry Eye Disease (DED), blepharitis and meibomian gland dysfunction (MDG), allergic eye diseases (AED), chemical and thermal burns; all these conditions can severely affect eyesight and quality of life, and sometime even blindness. Patients with OSD can develop photophobia, corneal scarring, intermittent blurred vision, pain, limited ability to perform daily activities, reduced vitality, poor general health and, in many cases, depression.
Glaucoma, one of the leading causes of irreversible blindness, is an optic neuropathy characterized by thinning of retinal nerve fiber layer and increase of optic disc cupping , whose main risk factor is closely related to the intraocular pressure (IOP) levels. Thus, the management of the disease consists in the lowering IOP through medical, laser or surgical therapy . However, IOP reduction is most commonly achieved using topical ocular medications, which often contain preservatives employed to maintain stability and sterility of the product. Preservatives can be associated with undesirable adverse effects such as allergy, local irritation and inflammation . The long-term use of anti-glaucoma medications produces several alterations of ocular surface components, especially at the conjunctival level where epithelial modifications, dendritic cell activation, conjunctiva-associated lymphoid tissue activation, and goblet cell (GCs) loss easily occur GCs play crucial tasks in the homeostasis of the ocular surface being the main source of mucoproteins, essential to maintain tear film stability. Thus, the loss of GCs progressively leads to the happening of an iatrogenic OSD . Moreover, advancing age is a significant risk factor for both OSD and glaucoma, further complicated by treatments for each condition, which can interact among them and yield counterproductive effects . For these reason glaucoma is often associated with OSD .Ocular surface inflammation is crucial in the pathophysiology of OSD, therefore anti-inflammatory therapy, including corticosteroids, may be of benefit to OSD patients . However, in susceptible individuals steroid-induced glaucoma or ocular hypertension can occur after steroid use. Individuals who develop an increase in IOP following steroid use are referred to as "steroid responders" . In a recent study Kallab et al. have found that dry eye treatment with low hydrocortisone dose reduced ocular inflammation without inducing increases in IOP ; glaucomatous patients were excluded from this study. Herein we evaluate the safety and efficacy of hydrocortisone eye drops in the treatment of OSD patients with and without glaucoma.
- Conditions
- Ocular Surface Disease, Glaucoma
- Being tested
- Hydrocortisone (CORTIVIS ®)
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone (CORTIVIS ®)Drug
Once enrolled all the patients had to instill topical low dose (1,005 mg) preservative-free hydrocortisone (CORTIVIS ®- Medivis, Catania, Italy) 2 times daily in each eye for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A: glaucoma | Experimental | OSD patients with glaucoma Receives: Drug: Hydrocortisone (CORTIVIS ®) |
| Group B: no glaucoma | Active comparator | OSD patients without glaucoma Receives: Drug: Hydrocortisone (CORTIVIS ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure(IOP)
IOP evaluation at time zero (T0), after 1 (T1) and two weeks of therapy (T2).
Measured: 2 weeks
OSDI (Ocular Surface Disease Index) questionnaire
OSDI record at time zero (T0), after 1 (T1) and two weeks of therapy (T2).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start4 Nov 2019
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ocular Surface DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Collaborators
- Medivis SRL
- Responsible party
- Principal investigator, Ciro Costagliola, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536129
- Sponsor's protocol ID
- CTS 11/2019
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khanna RC. Ocular surface disorders. Community Eye Health. 2017;30(99):S1-S2. No abstract available.
PubMed 29849435Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct;15(4):802-812. doi: 10.1016/j.jtos.2017.08.003. Epub 2017 Aug 8.
PubMed 28797892Lanza M, Gironi Carnevale UA, Mele L, Bifani Sconocchia M, Bartollino S, Costagliola C. Morphological and Functional Evaluation of Oral Citicoline Therapy in Chronic Open-Angle Glaucoma Patients: A Pilot Study With a 2-Year Follow-Up. Front Pharmacol. 2019 Sep 26;10:1117. doi: 10.3389/fphar.2019.01117. eCollection 2019.
PubMed 31611797Mohammed I, Kulkarni B, Faraj LA, Abbas A, Dua HS, King AJ. Profiling ocular surface responses to preserved and non-preserved topical glaucoma medications: A 2-year randomized evaluation study. Clin Exp Ophthalmol. 2020 Sep;48(7):973-982. doi: 10.1111/ceo.13814. Epub 2020 Jul 27.
PubMed 32564453Rossi GC, Pasinetti GM, Scudeller L, Bianchi PE. Ocular surface disease and glaucoma: how to evaluate impact on quality of life. J Ocul Pharmacol Ther. 2013 May;29(4):390-4. doi: 10.1089/jop.2011.0159. Epub 2012 Dec 7.
PubMed 23215770Rossi GC, Pasinetti GM, Scudeller L, Raimondi M, Lanteri S, Bianchi PE. Risk factors to develop ocular surface disease in treated glaucoma or ocular hypertension patients. Eur J Ophthalmol. 2013 May-Jun;23(3):296-302. doi: 10.5301/ejo.5000220. Epub 2012 Dec 17.
PubMed 23335308Kallab M, Szegedi S, Hommer N, Stegmann H, Kaya S, Werkmeister RM, Schmidl D, Schmetterer L, Garhofer G. Correction to: Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Trial. Adv Ther. 2020 Jan;37(1):342-343. doi: 10.1007/s12325-019-01190-3.
PubMed 31823206Filippelli M, dell'Omo R, Gelso A, Rinaldi M, Bartollino S, Napolitano P, Russo A, Campagna G, Costagliola C. Effects of topical low-dose preservative-free hydrocortisone on intraocular pressure in patients affected by ocular surface disease with and without glaucoma. Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):247-253. doi: 10.1007/s00417-021-05345-3. Epub 2021 Aug 18.
PubMed 34406502
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure in Patients With and Without Glaucoma
- ClinicalTrials.gov ID
- NCT04536129
- Acronym / sponsor ID
- CTS 11/2019
- Conditions
- Ocular Surface Disease, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Collaborators
- Medivis SRL
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 2 Sep 2020 (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.
Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD (ocular surface disease) patients with and without glaucoma.
Detailed description
The ocular surface comprises the cornea, conjunctiva, eyelids and lacrimal glands and any disorder in these structures can be classified as an ocular surface disorder (OSD). OSD includes Dry Eye Disease (DED), blepharitis and meibomian gland dysfunction (MDG), allergic eye diseases (AED), chemical and thermal burns; all these conditions can severely affect eyesight and quality of life, and sometime even blindness. Patients with OSD can develop photophobia, corneal scarring, intermittent blurred vision, pain, limited ability to perform daily activities, reduced vitality, poor general health and, in many cases, depression.
Glaucoma, one of the leading causes of irreversible blindness, is an optic neuropathy characterized by thinning of retinal nerve fiber layer and increase of optic disc cupping , whose main risk factor is closely related to the intraocular pressure (IOP) levels. Thus, the management of the disease consists in the lowering IOP through medical, laser or surgical therapy . However, IOP reduction is most commonly achieved using topical ocular medications, which often contain preservatives employed to maintain stability and sterility of the product. Preservatives can be associated with undesirable adverse effects such as allergy, local irritation and inflammation . The long-term use of anti-glaucoma medications produces several alterations of ocular surface components, especially at the conjunctival level where epithelial modifications, dendritic cell activation, conjunctiva-associated lymphoid tissue activation, and goblet cell (GCs) loss easily occur GCs play crucial tasks in the homeostasis of the ocular surface being the main source of mucoproteins, essential to maintain tear film stability. Thus, the loss of GCs progressively leads to the happening of an iatrogenic OSD . Moreover, advancing age is a significant risk factor for both OSD and glaucoma, further complicated by treatments for each condition, which can interact among them and yield counterproductive effects . For these reason glaucoma is often associated with OSD .Ocular surface inflammation is crucial in the pathophysiology of OSD, therefore anti-inflammatory therapy, including corticosteroids, may be of benefit to OSD patients . However, in susceptible individuals steroid-induced glaucoma or ocular hypertension can occur after steroid use. Individuals who develop an increase in IOP following steroid use are referred to as "steroid responders" . In a recent study Kallab et al. have found that dry eye treatment with low hydrocortisone dose reduced ocular inflammation without inducing increases in IOP ; glaucomatous patients were excluded from this study. Herein we evaluate the safety and efficacy of hydrocortisone eye drops in the treatment of OSD patients with and without glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: glaucoma | Experimental | Drug: Hydrocortisone (CORTIVIS ®)OSD patients with glaucoma |
| Group B: no glaucoma | Active comparator | Drug: Hydrocortisone (CORTIVIS ®)OSD patients without glaucoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age of at least 18 years
- diagnosis of OSD (Ocular Surface Disease)
- normal ophthalmic findings except history of OSD for at least 3 months, and current therapy with topical lubricants for at least 3 months
- POAG (primary open-angle glaucoma ) patients on medical therapy
Key exclusion criteria (17 listed)
- clinically significant slit lamp findings at screening visit except OSD
- participation in a clinical trial in the 4 weeks preceding the screening visit
- symptoms of a clinically relevant illness in the 3 weeks before the screening visit
- presence/ history of a severe medical or surgical condition
- intake of parasympathomimetic or antipsychotic drugs
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 |
|---|---|---|
| Hydrocortisone (CORTIVIS ®)Once enrolled all the patients had to instill topical low dose (1,005 mg) preservative-free hydrocortisone (CORTIVIS ®- Medivis, Catania, Italy) 2 times daily in each eye for two weeks. | Drug | Group A: glaucoma, Group B: no glaucoma |
Primary outcome
Intraocular pressure(IOP)
Time frame: 2 weeks
IOP evaluation at time zero (T0), after 1 (T1) and two weeks of therapy (T2).
OSDI (Ocular Surface Disease Index) questionnaire
Time frame: 2 weeks
OSDI record at time zero (T0), after 1 (T1) and two weeks of therapy (T2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Results publication: PubMed 29849435Khanna RC. Ocular surface disorders. Community Eye Health. 2017;30(99):S1-S2. No abstract available.
- Results publication: PubMed 28797892Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct;15(4):802-812. doi: 10.1016/j.jtos.2017.08.003. Epub 2017 Aug 8.
- Results publication: PubMed 31611797Lanza M, Gironi Carnevale UA, Mele L, Bifani Sconocchia M, Bartollino S, Costagliola C. Morphological and Functional Evaluation of Oral Citicoline Therapy in Chronic Open-Angle Glaucoma Patients: A Pilot Study With a 2-Year Follow-Up. Front Pharmacol. 2019 Sep 26;10:1117. doi: 10.3389/fphar.2019.01117. eCollection 2019.
- Results publication: PubMed 32564453Mohammed I, Kulkarni B, Faraj LA, Abbas A, Dua HS, King AJ. Profiling ocular surface responses to preserved and non-preserved topical glaucoma medications: A 2-year randomized evaluation study. Clin Exp Ophthalmol. 2020 Sep;48(7):973-982. doi: 10.1111/ceo.13814. Epub 2020 Jul 27.
- Results publication: PubMed 23215770Rossi GC, Pasinetti GM, Scudeller L, Bianchi PE. Ocular surface disease and glaucoma: how to evaluate impact on quality of life. J Ocul Pharmacol Ther. 2013 May;29(4):390-4. doi: 10.1089/jop.2011.0159. Epub 2012 Dec 7.
- Results publication: PubMed 23335308Rossi GC, Pasinetti GM, Scudeller L, Raimondi M, Lanteri S, Bianchi PE. Risk factors to develop ocular surface disease in treated glaucoma or ocular hypertension patients. Eur J Ophthalmol. 2013 May-Jun;23(3):296-302. doi: 10.5301/ejo.5000220. Epub 2012 Dec 17.
- Results publication: PubMed 31823206Kallab M, Szegedi S, Hommer N, Stegmann H, Kaya S, Werkmeister RM, Schmidl D, Schmetterer L, Garhofer G. Correction to: Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Trial. Adv Ther. 2020 Jan;37(1):342-343. doi: 10.1007/s12325-019-01190-3.
- Derived from this study: PubMed 34406502Filippelli M, dell'Omo R, Gelso A, Rinaldi M, Bartollino S, Napolitano P, Russo A, Campagna G, Costagliola C. Effects of topical low-dose preservative-free hydrocortisone on intraocular pressure in patients affected by ocular surface disease with and without glaucoma. Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):247-253. doi: 10.1007/s00417-021-05345-3. Epub 2021 Aug 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone (CORTIVIS ®) in people with Ocular Surface Disease and Glaucoma, run by University of Molise at 1 site 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 4 inclusion and 17 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 1 Oct 2021. 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 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 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?
Intraocular pressure(IOP) (time frame: 2 weeks). 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 NCT04536129, which also lists 8 linked publications.
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 1 Oct 2021.