KeratitisPhase 3NCT05689996
Ozone-based Eye Drops as Adjuvant Therapy in Microbial Keratitis
A Phase 3 study testing Ozone-Based Agent in people with Keratitis, run by Assiut University.
Trial summary
To compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis . The therapeutic response will be evaluated with clinical examination follow up . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Keratitis
- What is being tested?
- Ozone-Based Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to 1 May 2023
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with active microbial keratitis ( bacterial , viral or fungal )
- with positive culture and sensitivity result
- Any age group.
- accepting well informed consent for using the ozone eye drops
Who cannot join
- patients refuse to participate
- Patients with other forms of keratitis rather than infective keratitis . patients who will not complete treatment .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Using of Ozone-based Eye Drops as Adjuvant Therapy in the Management of Microbial Keratitis in Comparison to the Conventional Therapy
To compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis . The therapeutic response will be evaluated with clinical examination follow up .
Read the detailed description
Inflammatory corneal diseases remain a major challenge in ophthalmology , for example microbial keratitis still remains a serious cause of corneal opacity and subsequently visual impairment worldwide [1,2,3 ]. Rarely the infection occurs in the normal eye as the human cornea has its natural resistance against infection. However, predisposing factors such as pre-existing corneal disease, contact lens wear , aggressive topical antimicrobial therapy , prior ocular surgery , ocular surface disease, and trauma may change the defense mechanisms of the ocular surfaces and thereafter permit entry of different pathogens. Treatment aims to managing any other associated ocular surface disease involvement, removing any known risk factors in addition to antimicrobial therapy . The patient requires close treatment response monitoring, sometimes including hospitalization followed by frequent outpatient visits. The risk of developing microbial keratitis and the severity of the disease depend on both the type of the infecting organism and the condition of the ocular surface .[4] .It is important to confirm infection in order to determine the most effective treatment, especially at the initial stage when the treatment is not based on culture results. Microbial keratitis is treated by topical eye drops containing anti-inflammatory and anti- bacterial agents. The current antimicrobial treatments often lack efficacy because infections occur in hypoxic tissue contain methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa so new products for the treatment of ocular inflammation and pain are needed. In addition, Increased bacterial antibiotic resistance contributes to the use of a therapy based on natural products, such as ozonized oil, which have a wide spectrum of antimicrobial effects for therapeutic applications.
The use of ozone in anterior segment pathologies could be providential due to its anti-inflammatory and bactericidal activity by direct oxidation mediated by lipoperoxyde and hydrogen peroxide, selective cytotoxicity on fast dividing cells, through bacterial lysis then cell death and negative regulation on mitochondrial activity in bacteria.[5] .Ozone dose trigger several useful biochemical mechanisms and reactivate the antioxidant system (i.e., catalase, superoxide dismutase, glutathione peroxidase, etc.) [ 6] in addition to promoting tissue repair properties , assumed to be due to the upregulation of platelet-derived growth factor, transforming growth factor-β, and vascular endothelial growth factor expressions. Eye drops containing ozone were recently used in the management of ocular surface infection caused by bacteria, viruses and fungi, [ 7-9] and a specific formulation containing liposomal ozonated sunflower oil (Ozodrop®, FB Vision, San Benedetto del Tronto, Italy) that is well tolerated by the ocular surface has been developed. [ 10 ] Ozone in the gaseous state is extremely reactive and not always suitable as a topical treatment. In saline solution, its concentration reduces quickly with a first-order kinetics and its half-life is 2 h: this means that in about 24 h very little ozone will be remains in the solution . In spite of its instability, the ozone molecule can be stabilized - for topical use - as an ozonide, an organic analog of ozone, formed by the reaction of ozone with an unsaturated fatty acid , such as oleic acid [ 12-11] . The zone eye drops will be used at regimen of 3 times per day in addition of antibiotics eye drops.
To superintend its effectiveness in dealing with microbial keratitis , assessment of visual acuity outcome , clinical examination , a follow up imaging from slit lamp will be done and an imaging modality as Anterior segment optical coherence tomography (ASOCT ) can be done . ASOCT is a relatively new imaging modality in the imaging field towards a better evaluation, diagnosis and management of many anterior segment diseases [13,14] .Current uses of ASOCT are corneal thickness evaluation , depth of corneal deposits and lesions including dystrophies, details of corneal inflammation, dry eye evaluation and diagnosis of surface neoplasia in early stages [ 15].Its purpose in this study is to describe the ASOCT cornea features during active stage of microbial keratitis and to evaluate its contribution for its diagnosis and the follow-up Images acquired by AS OCT will be compared to the clinical assessment .
- Conditions
- Keratitis
- Being tested
- Ozone-Based Agent
- Keywords
- Microbial keratitis
- Medical subject headings
- Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone-Based AgentDrug
Also called ozone-based eye drops
Ozone-based eye drops as adjuvant therapy in microbial keratitis
| Study group | Role | What they receive |
|---|---|---|
| Infective keratitis | Experimental | Preparation of nanostructure lipid carriers (NLCs):
The emulsification-solvent evaporation technique was used to prepare the NLCs. The method was followed by ultrasonication as reported [1]. In brief, the lipid phase was composed of stearic acid (solid lipid, 300 mg and oleic acid (liquid lipid, 300 mg) dissolved in ethanol (2 mL, 1:1, v/v) at 70oC. In total, 20 mL of the distilled water containing 2% of the Tween® 80 were heated at 70 oC to prepare the aqueous phase. Then, both phases, aqueous and lipid phases, were mixed at the same temperature using 2000 rpm stirring for 15 min. The resulting pre-emulsion obtained from the mixture of the aqueous and lipid phases was sonicated by a probe-type sonicator (Cole-Parmer, Vernon Hills, IL, USA) for 10 min at pulse-ON for 3 s and pulse-OFF for 5 s (40 W). The obtained dispersion was allowed to cool to RT under continuous stirring for 60 min at 1000 rpm for 1 h to obtain the NLCs dispersions. Receives: Drug: Ozone-Based Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ozone-based eye drops as adjuvant therapy in microbial keratitis
compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis.
Main outcome measurements include decrease in size, depth and infiltrate of the ulcer in millimeters measured on slit lamp biomicroscopy .
Measured: at 48 hours , 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for KeratitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Preparation of nanostructure lipid carriers (NLCs): The emulsification-solvent evaporation technique was used to prepare the NLCs. The method was followed by ultrasonication as reported \[1\]. In brief, the lipid phase was composed of stearic acid (solid lipid, 300 mg and oleic acid (liquid lipid, 300 mg) dissolved in ethanol (2 mL, 1:1, v/v) at 70oC. In total, 20 mL of the distilled water containing 2% of the Tween® 80 were heated at 70 oC to prepare the aqueous phase. Then, both phases, aqueous and lipid phases, were mixed at the same temperature using 2000 rpm stirring for 15 min. The resulting pre-emulsion obtained from the mixture of the aqueous and lipid phases was sonicated by a probe-type sonicator (Cole-Parmer, Vernon Hills, IL, USA) for 10 min at pulse-ON for 3 s and pulse-OFF for 5 s (40 W). The obtained dispersion was allowed to cool to RT under continuous stirring for 60 min at 1000 rpm for 1 h to obtain the NLCs dispersions.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Abdel-Fattah Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689996
- Sponsor's protocol ID
- Ozone-based eye drops
- Status last verified
- Jan 2023
- First submitted
- 11 Oct 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spadea L, Tonti E, Spaterna A, Marchegiani A. Use of Ozone-Based Eye Drops: A Series of Cases in Veterinary and Human Spontaneous Ocular Pathologies. Case Rep Ophthalmol. 2018 May 24;9(2):287-298. doi: 10.1159/000488846. eCollection 2018 May-Aug.
PubMed 29928225Paduch R, Urbanik-Sypniewska T, Kutkowska J, Choragiewicz T, Matysik-Wozniak A, Zweifel S, Czarnek-Chudzik A, Zaluska W, Rejdak R, Toro MD. Ozone-Based Eye Drops Activity on Ocular Epithelial Cells and Potential Pathogens Infecting the Front of the Eye. Antioxidants (Basel). 2021 Jun 16;10(6):968. doi: 10.3390/antiox10060968.
PubMed 34208703Passidomo F, Pignatelli F, Addabbo G, Costagliola C. Topical Liposomal Ozonated Oil in Complicated Corneal Disease: A Report on Three Clinical Cases. Int Med Case Rep J. 2021 May 14;14:327-332. doi: 10.2147/IMCRJ.S311839. eCollection 2021.
PubMed 34017203Sridhar MS, Martin R. Anterior segment optical coherence tomography for evaluation of cornea and ocular surface. Indian J Ophthalmol. 2018 Mar;66(3):367-372. doi: 10.4103/ijo.IJO_823_17.
PubMed 29480245
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using of Ozone-based Eye Drops as Adjuvant Therapy in the Management of Microbial Keratitis in Comparison to the Conventional Therapy
- ClinicalTrials.gov ID
- NCT05689996
- Acronym / sponsor ID
- Ozone-based eye drops
- Conditions
- Keratitis
- Keywords
- Microbial keratitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 19 Jan 2023 (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.
To compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis . The therapeutic response will be evaluated with clinical examination follow up .
Detailed description
Inflammatory corneal diseases remain a major challenge in ophthalmology , for example microbial keratitis still remains a serious cause of corneal opacity and subsequently visual impairment worldwide [1,2,3 ]. Rarely the infection occurs in the normal eye as the human cornea has its natural resistance against infection. However, predisposing factors such as pre-existing corneal disease, contact lens wear , aggressive topical antimicrobial therapy , prior ocular surgery , ocular surface disease, and trauma may change the defense mechanisms of the ocular surfaces and thereafter permit entry of different pathogens. Treatment aims to managing any other associated ocular surface disease involvement, removing any known risk factors in addition to antimicrobial therapy . The patient requires close treatment response monitoring, sometimes including hospitalization followed by frequent outpatient visits. The risk of developing microbial keratitis and the severity of the disease depend on both the type of the infecting organism and the condition of the ocular surface .[4] .It is important to confirm infection in order to determine the most effective treatment, especially at the initial stage when the treatment is not based on culture results. Microbial keratitis is treated by topical eye drops containing anti-inflammatory and anti- bacterial agents. The current antimicrobial treatments often lack efficacy because infections occur in hypoxic tissue contain methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa so new products for the treatment of ocular inflammation and pain are needed. In addition, Increased bacterial antibiotic resistance contributes to the use of a therapy based on natural products, such as ozonized oil, which have a wide spectrum of antimicrobial effects for therapeutic applications.
The use of ozone in anterior segment pathologies could be providential due to its anti-inflammatory and bactericidal activity by direct oxidation mediated by lipoperoxyde and hydrogen peroxide, selective cytotoxicity on fast dividing cells, through bacterial lysis then cell death and negative regulation on mitochondrial activity in bacteria.[5] .Ozone dose trigger several useful biochemical mechanisms and reactivate the antioxidant system (i.e., catalase, superoxide dismutase, glutathione peroxidase, etc.) [ 6] in addition to promoting tissue repair properties , assumed to be due to the upregulation of platelet-derived growth factor, transforming growth factor-β, and vascular endothelial growth factor expressions. Eye drops containing ozone were recently used in the management of ocular surface infection caused by bacteria, viruses and fungi, [ 7-9] and a specific formulation containing liposomal ozonated sunflower oil (Ozodrop®, FB Vision, San Benedetto del Tronto, Italy) that is well tolerated by the ocular surface has been developed. [ 10 ] Ozone in the gaseous state is extremely reactive and not always suitable as a topical treatment. In saline solution, its concentration reduces quickly with a first-order kinetics and its half-life is 2 h: this means that in about 24 h very little ozone will be remains in the solution . In spite of its instability, the ozone molecule can be stabilized - for topical use - as an ozonide, an organic analog of ozone, formed by the reaction of ozone with an unsaturated fatty acid , such as oleic acid [ 12-11] . The zone eye drops will be used at regimen of 3 times per day in addition of antibiotics eye drops.
To superintend its effectiveness in dealing with microbial keratitis , assessment of visual acuity outcome , clinical examination , a follow up imaging from slit lamp will be done and an imaging modality as Anterior segment optical coherence tomography (ASOCT ) can be done . ASOCT is a relatively new imaging modality in the imaging field towards a better evaluation, diagnosis and management of many anterior segment diseases [13,14] .Current uses of ASOCT are corneal thickness evaluation , depth of corneal deposits and lesions including dystrophies, details of corneal inflammation, dry eye evaluation and diagnosis of surface neoplasia in early stages [ 15].Its purpose in this study is to describe the ASOCT cornea features during active stage of microbial keratitis and to evaluate its contribution for its diagnosis and the follow-up Images acquired by AS OCT will be compared to the clinical assessment .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Preparation of nanostructure lipid carriers (NLCs): The emulsification-solvent evaporation technique was used to prepare the NLCs. The method was followed by ultrasonication as reported [1]. In brief, the lipid phase was composed of stearic acid (solid lipid, 300 mg and oleic acid (liquid lipid, 300 mg) dissolved in ethanol (2 mL, 1:1, v/v) at 70oC. In total, 20 mL of the distilled water containing 2% of the Tween® 80 were heated at 70 oC to prepare the aqueous phase. Then, both phases, aqueous and lipid phases, were mixed at the same temperature using 2000 rpm stirring for 15 min. The resulting pre-emulsion obtained from the mixture of the aqueous and lipid phases was sonicated by a probe-type sonicator (Cole-Parmer, Vernon Hills, IL, USA) for 10 min at pulse-ON for 3 s and pulse-OFF for 5 s (40 W). The obtained dispersion was allowed to cool to RT under continuous stirring for 60 min at 1000 rpm for 1 h to obtain the NLCs dispersions.
| Arm | Type | Receives |
|---|---|---|
| Infective keratitis | Experimental | Drug: Ozone-Based AgentPreparation of nanostructure lipid carriers (NLCs): The emulsification-solvent evaporation technique was used to prepare the NLCs. The method was followed by ultrasonication as reported [1]. In brief, the lipid phase was composed of stearic acid (solid lipid, 300 mg and oleic acid (liquid lipid, 300 mg) dissolved in ethanol (2 mL, 1:1, v/v) at 70oC. In total, 20 mL of the distilled water containing 2% of the Tween® 80 were heated at 70 oC to prepare the aqueous phase. Then, both phases, aqueous and lipid phases, were mixed at the same temperature using 2000 rpm stirring for 15 min. The resulting pre-emulsion obtained from the mixture of the aqueous and lipid phases was sonicated by a probe-type sonicator (Cole-Parmer, Vernon Hills, IL, USA) for 10 min at pulse-ON for 3 s and pulse-OFF for 5 s (40 W). The obtained dispersion was allowed to cool to RT under continuous stirring for 60 min at 1000 rpm for 1 h to obtain the NLCs dispersions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with active microbial keratitis ( bacterial , viral or fungal )
- with positive culture and sensitivity result
- Any age group.
- accepting well informed consent for using the ozone eye drops
Key exclusion criteria (2 listed)
- patients refuse to participate
- Patients with other forms of keratitis rather than infective keratitis . patients who will not complete treatment .
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 |
|---|---|---|
| Ozone-Based AgentAlso: ozone-based eye dropsOzone-based eye drops as adjuvant therapy in microbial keratitis | Drug | Infective keratitis |
Primary outcome
Ozone-based eye drops as adjuvant therapy in microbial keratitis
Time frame: at 48 hours , 2-3 weeks
compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis. Main outcome measurements include decrease in size, depth and infiltrate of the ulcer in millimeters measured on slit lamp biomicroscopy .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 29928225Spadea L, Tonti E, Spaterna A, Marchegiani A. Use of Ozone-Based Eye Drops: A Series of Cases in Veterinary and Human Spontaneous Ocular Pathologies. Case Rep Ophthalmol. 2018 May 24;9(2):287-298. doi: 10.1159/000488846. eCollection 2018 May-Aug.
- Background: PubMed 34208703Paduch R, Urbanik-Sypniewska T, Kutkowska J, Choragiewicz T, Matysik-Wozniak A, Zweifel S, Czarnek-Chudzik A, Zaluska W, Rejdak R, Toro MD. Ozone-Based Eye Drops Activity on Ocular Epithelial Cells and Potential Pathogens Infecting the Front of the Eye. Antioxidants (Basel). 2021 Jun 16;10(6):968. doi: 10.3390/antiox10060968.
- Background: PubMed 34017203Passidomo F, Pignatelli F, Addabbo G, Costagliola C. Topical Liposomal Ozonated Oil in Complicated Corneal Disease: A Report on Three Clinical Cases. Int Med Case Rep J. 2021 May 14;14:327-332. doi: 10.2147/IMCRJ.S311839. eCollection 2021.
- Background: PubMed 29480245Sridhar MS, Martin R. Anterior segment optical coherence tomography for evaluation of cornea and ocular surface. Indian J Ophthalmol. 2018 Mar;66(3):367-372. doi: 10.4103/ijo.IJO_823_17.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ozone-Based Agent in people with Keratitis, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer Abdel-Fattah (1064464974, abeerabdelfattah1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ozone-based eye drops as adjuvant therapy in microbial keratitis (time frame: at 48 hours , 2-3 weeks). 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 NCT05689996, which also lists 4 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 19 Jan 2023.