Eye Infections, BacterialPhase 1NCT00357292
Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers
A Phase 1 study testing Azithromycin (T1225) in people with Eye Infections, Bacterial, run by Laboratoires Thea.
Trial summary
To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Infections, Bacterial
- What is being tested?
- Azithromycin (T1225)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2002to Apr 2002
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged from 18 to 45 years old;
- Written informed consent;
- Healthy volunteers (without any ocular symptom);
- Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - Slit lamp examination without clinical relevant abnormalities - Tear break-up time (BUT) ≥10 seconds - Lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - Lissamine green test total score < 4 +).
Who cannot join
- Ocular trauma, infection or inflammation within the last 3 months;
- Blepharitis;
- Conjunctival hyperaemia (score >= 2 +);
- Watering (score >= 2);
- Contact lenses;
- Ocular surgery, including LASIK and PRK, within the last 12 months;
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- Topical ocular treatment within the last month;
- Systemic antibiotics within the last 7 days;
- Any medication during the study (except: Paracetamol and contraceptives).
About this study
Official title: Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers
To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation
Read the detailed description
The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.
- Conditions
- Eye Infections, Bacterial
- Being tested
- Azithromycin (T1225)
- Medical subject headings
- Eye Infections, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin (T1225)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular subjective symptoms
Ocular objective symptoms
Secondary outcomes (2)
Ocular pharmacokinetic.
Ocular and systemic adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startMar 2002
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Infections, BacterialStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Khalid TABBARA, Professor, Principal investigator, The Eye Center, Riyadh (Saudi Arabia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357292
- Sponsor's protocol ID
- LT1225-PI1-09/01(AS)
- Status last verified
- Jul 2006
- First submitted
- 25 Jul 2006
- Last updated
- 27 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00357292
- Acronym / sponsor ID
- LT1225-PI1-09/01(AS)
- Conditions
- Eye Infections, Bacterial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Apr 2002
- First posted
- 27 Jul 2006 (estimated)
- 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 ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation
Detailed description
The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female aged from 18 to 45 years old;
- Written informed consent;
- Healthy volunteers (without any ocular symptom);
- Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - Slit lamp examination without clinical relevant abnormalities - Tear break-up time (BUT) ≥10 seconds - Lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - Lissamine green test total score < 4 +).
Key exclusion criteria (9 listed)
- Ocular trauma, infection or inflammation within the last 3 months;
- Blepharitis;
- Conjunctival hyperaemia (score >= 2 +);
- Watering (score >= 2);
- Contact lenses;
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 |
|---|---|---|
| Azithromycin (T1225) | Drug | – |
Primary outcome
Ocular subjective symptoms
Ocular objective symptoms
2 secondary outcomes
Ocular pharmacokinetic.
Ocular and systemic adverse events.
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 27 Jul 2006.
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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.
Khalid TABBARA, Professor principal investigator
The Eye Center, Riyadh (Saudi Arabia)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin (T1225) in people with Eye Infections, Bacterial, run by Laboratoires Thea.
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 9 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 27 Jul 2006. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Ocular subjective symptoms. 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 27 Jul 2006.