Outcomes of Cyclosporine Eye Drops in Herpetic KeratitisPhase 4NCT05720715
Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis
A Phase 4 study testing cyclosporine A 0.05% eye drops in people with Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis, run by Farwaniya Hospital at 1 site in Kuwait.
Trial summary
Objective: To compare the additive effect of topical cyclosporine A 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis
- What is being tested?
- cyclosporine A 0.05% eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Jan 2022to 1 Mar 2024
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with herpetic stromal keratitis
Who cannot join
- associated ocular diseases, DM, renal disease, pregnancy, breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of Cyclosporine A 0.05% Eye Drops in Management of Non- Necrotizing Herpetic Stromal Keratitis; a Prospective Controlled Clinical Trial
Objective: To compare the additive effect of topical cyclosporine A 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis.
Methods: Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops.
Read more
Group B: receive topical prednisolone with placebo eye drops (tear replacement).
The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months.
- Being tested
- cyclosporine A 0.05% eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine A 0.05% eye dropsDrug
Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops.
Group B: receive topical prednisolone with placebo eye drops (tear replacement).
The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | receive cyclosporine eye drops together with prednisolone eye drops. Receives: Drug: cyclosporine A 0.05% eye drops |
| group B | Placebo comparator | receive topical prednisolone with placebo eye drops (tear replacement). Receives: Drug: cyclosporine A 0.05% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of ttt
duration of treatment until complete resolving of keratitis
Measured: 3 months
Secondary outcomes (1)
improvement in visual acuity
by snellen chart
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Outcomes of Cyclosporine Eye Drops in Herpetic KeratitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farwaniya Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nancy Lotfy, MD, Farwaniya Hospital
- Investigators
- Salah Al-rasheedy, MD, Study chair, Farwaniya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720715
- Sponsor's protocol ID
- 7080
- Status last verified
- Aug 2024
- First submitted
- 31 Jan 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lotfy NM, Alshatti H, Khachaba RY, Hagras SM. Evaluation of safety and efficacy of cyclosporine-A eye drops in herpetic stromal keratitis: a prospective randomized clinical trial. J Ophthalmic Inflamm Infect. 2026 Mar 5;16(1):14. doi: 10.1186/s12348-026-00573-2.
PubMed 41784713
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Cyclosporine A 0.05% Eye Drops in Management of Non- Necrotizing Herpetic Stromal Keratitis; a Prospective Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05720715
- Acronym / sponsor ID
- 7080
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Farwaniya HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 9 Feb 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.
Objective: To compare the additive effect of topical cyclosporine A 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis.
Methods: Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops.
Group B: receive topical prednisolone with placebo eye drops (tear replacement).
The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: cyclosporine A 0.05% eye dropsreceive cyclosporine eye drops together with prednisolone eye drops. |
| group B | Placebo comparator | Drug: cyclosporine A 0.05% eye dropsreceive topical prednisolone with placebo eye drops (tear replacement). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with herpetic stromal keratitis
Key exclusion criteria (1 listed)
- associated ocular diseases, DM, renal disease, pregnancy, breast feeding.
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 |
|---|---|---|
| cyclosporine A 0.05% eye dropsPatients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops. Group B: receive topical prednisolone with placebo eye drops (tear replacement). The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months. | Drug | group A, group B |
Primary outcome
duration of ttt
Time frame: 3 months
duration of treatment until complete resolving of keratitis
1 secondary outcome
improvement in visual acuity
Time frame: 3 months
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 7 Aug 2024.
- Derived from this study: PubMed 41784713Lotfy NM, Alshatti H, Khachaba RY, Hagras SM. Evaluation of safety and efficacy of cyclosporine-A eye drops in herpetic stromal keratitis: a prospective randomized clinical trial. J Ophthalmic Inflamm Infect. 2026 Mar 5;16(1):14. doi: 10.1186/s12348-026-00573-2.
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.
Salah Al-rasheedy, MD study chair
Farwaniya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cyclosporine A 0.05% eye drops in people with Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis, run by Farwaniya Hospital at 1 site in Kuwait.
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 1 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 7 Aug 2024. 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 Kuwait. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
duration of ttt (time frame: 3 months). 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 NCT05720715, which also lists 1 linked publication.
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 7 Aug 2024.