Herpetic KeratitisNCT06757907
Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis
A study testing Acyclovir 400 MG and Ganciclovir (GCV) in people with Herpetic Keratitis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Traditional antiviral treatments, including systemic acyclovir, have shown effectiveness in resolving keratitis but can also lead to complications, including ocular surface toxicity and the development of acyclovir-resistant strains of HSV. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Herpetic Keratitis
- What is being tested?
- Acyclovir 400 MG and Ganciclovir (GCV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 25 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with herpetic keratitis
Who cannot join
- Patients with known allergies to ganciclovir or acyclovir
- Severe ocular surface disease
- Those who have previously received antiviral therapy for herpetic keratitis within the last month
Trial locations and contacts
1 site in 1 country.
About this study
Traditional antiviral treatments, including systemic acyclovir, have shown effectiveness in resolving keratitis but can also lead to complications, including ocular surface toxicity and the development of acyclovir-resistant strains of HSV. Topical ganciclovir 0.15% ophthalmic gel presents a safer alternative for managing herpetic keratitis, offering effective viral suppression with minimal toxicity. This study aims to compare the efficacy and safety of topical ganciclovir versus systemic acyclovir in treating herpetic keratitis, providing valuable insights into optimal management strategies for this condition
- Conditions
- Herpetic Keratitis
- Being tested
- Acyclovir 400 MG, Ganciclovir (GCV)
- Keywords
- acyclovir, ganciclovir
- Medical subject headings
- Keratitis, Herpetic, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyclovir 400 MGDrug
Acyclovir is used to treat infections caused by certain types of viruses.
Ganciclovir (GCV)Drug
Ganciclovir is an anti-viral drug
| Study group | Role | What they receive |
|---|---|---|
| ganciclovir | Active comparator | Not described Receives: Drug: Ganciclovir (GCV) |
| Systemic acyclovir | Active comparator | Not described Receives: Drug: Acyclovir 400 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal healing
Heling of the keratitis
Measured: At 4 and 6 weeks
Secondary outcomes (1)
Sie effects
Measuring the percentage of the side effects of the drugs
Measured: at 4 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Oct 2024
- Primary completion20 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpetic KeratitisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Tharwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757907
- Sponsor's protocol ID
- Herpetic Keratitis
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis
- ClinicalTrials.gov ID
- NCT06757907
- Acronym / sponsor ID
- Herpetic Keratitis
- Conditions
- Herpetic Keratitis
- Keywords
- acyclovir, ganciclovir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 3 Jan 2025 (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.
Traditional antiviral treatments, including systemic acyclovir, have shown effectiveness in resolving keratitis but can also lead to complications, including ocular surface toxicity and the development of acyclovir-resistant strains of HSV. Topical ganciclovir 0.15% ophthalmic gel presents a safer alternative for managing herpetic keratitis, offering effective viral suppression with minimal toxicity. This study aims to compare the efficacy and safety of topical ganciclovir versus systemic acyclovir in treating herpetic keratitis, providing valuable insights into optimal management strategies for this condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ganciclovir | Active comparator | Drug: Ganciclovir (GCV) |
| Systemic acyclovir | Active comparator | Drug: Acyclovir 400 MG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with herpetic keratitis
Key exclusion criteria (3 listed)
- Patients with known allergies to ganciclovir or acyclovir
- Severe ocular surface disease
- Those who have previously received antiviral therapy for herpetic keratitis within the last month
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 |
|---|---|---|
| Acyclovir 400 MGAcyclovir is used to treat infections caused by certain types of viruses. | Drug | Systemic acyclovir |
| Ganciclovir (GCV)Ganciclovir is an anti-viral drug | Drug | ganciclovir |
Primary outcome
Corneal healing
Time frame: At 4 and 6 weeks
Heling of the keratitis
1 secondary outcome
Sie effects
Time frame: at 4 and 6 weeks
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 3 Jan 2025.
- Individual participant dataSharing planned: Undecided
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A Study of the Safety, Tolerability and Prelinminary Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
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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 Acyclovir 400 MG and Ganciclovir (GCV) in people with Herpetic Keratitis, run by Al-Azhar University at 1 site in Egypt.
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 1 inclusion and 3 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 3 Jan 2025. 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 Egypt. 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?
Corneal healing (time frame: At 4 and 6 weeks). 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 3 Jan 2025.