Blepharo ConjunctivitisEarly Phase 1NCT03975374
To Study Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
A Early Phase 1 study testing Tobramycin/dexamethasone opthalmic solution and Tobradex Opthalmic Solution in people with Blepharo Conjunctivitis, run by Sutphin Drugs at 1 site in United States.
Trial summary
The objective of the study is to compare and describe efficacy and safety of Tobradex ophthalmic suspension versus generic Tobramycin/dexamethasone Suspension in treatment of Blepharoconjuctivitis through clinical parameters Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharo Conjunctivitis
- What is being tested?
- Tobramycin/dexamethasone opthalmic solution and Tobradex Opthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2019to 30 Jun 2020
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All potential subjects with symptomatic blepharitis examined to have blepharitis with healthy mental status, able to give consent, with/without co-existing medical conditions will be considered
Who cannot join
- All subjects with history and/or probable history of allergic reaction to tobramycin/dexamethasone and all subjects who have mental disability and are unable to give direct consent will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Sutphin Drugs
Jamaica, New York, 11435
Ajai Prakash, PhD, 718-326-0310, ajaiprakashny@gmail.com
Jayesh Patel, 5166414687, healingathome13@gmail.com
About this study
Official title: Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
The objective of the study is to compare and describe efficacy and safety of Tobradex ophthalmic suspension versus generic Tobramycin/dexamethasone Suspension in treatment of Blepharoconjuctivitis through clinical parameters
Read the detailed description
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter; Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
- Conditions
- Blepharo Conjunctivitis
- Being tested
- Tobramycin/dexamethasone opthalmic solution, Tobradex Opthalmic Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin/dexamethasone opthalmic solutionDrug
Also called Tobradex
To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution
Tobradex Opthalmic SolutionDrug
Tobradex Opthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin/Dexamethasone opthamic Solution | Experimental | This group of randomized patients will be instructed to instill 2 gtt of Tobramycin/Dexamethasone opthamic solution every 6 hours for 10 days Receives: Drug: Tobramycin/dexamethasone opthalmic solution |
| Tobradex Opthalmic Solution | Active comparator | This group of randomized patients will be instructed to instill 2 gtt of Tobradex Opthalmic Solution every 6 hours for 10 days Receives: Drug: Tobradex Opthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sign and symptoms composite score
The change from baseline in the signs and symptoms score. Global sign and symptom score defined as the total score of lid margin redness (0-3), lid swelling (0-4), bulbar conjunctival redness (0-3), palpebral conjunctival redness (0-3), ocular discharge (0-3), itchy eyelids (0-4), and gritty eyes (0-4).
The change from baseline to Day 10 (Visit 3 at day 1, day 7 and day 10) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start15 Jun 2019 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blepharo ConjunctivitisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In group one, patients will be instructed to instill 2 gtt of Tobradex ophthalmic solution for 10 days. In group two, patients will be instructed to instill 2 gtt of Tobramycin/dexamethasone solution for 10 days .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sutphin Drugs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Ajai Prakash, Sutphin Drugs
- Investigators
- Ajai Prakash, Principal investigator, Sutphin Drugs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975374
- Sponsor's protocol ID
- Sutphin T
- Status last verified
- Jun 2019
- First submitted
- 29 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
- ClinicalTrials.gov ID
- NCT03975374
- Acronym / sponsor ID
- Sutphin T
- Conditions
- Blepharo Conjunctivitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sutphin DrugsIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 5 Jun 2019 (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.
The objective of the study is to compare and describe efficacy and safety of Tobradex ophthalmic suspension versus generic Tobramycin/dexamethasone Suspension in treatment of Blepharoconjuctivitis through clinical parameters
Detailed description
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter; Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In group one, patients will be instructed to instill 2 gtt of Tobradex ophthalmic solution for 10 days. In group two, patients will be instructed to instill 2 gtt of Tobramycin/dexamethasone solution for 10 days .
| Arm | Type | Receives |
|---|---|---|
| Tobramycin/Dexamethasone opthamic Solution | Experimental | Drug: Tobramycin/dexamethasone opthalmic solutionThis group of randomized patients will be instructed to instill 2 gtt of Tobramycin/Dexamethasone opthamic solution every 6 hours for 10 days |
| Tobradex Opthalmic Solution | Active comparator | Drug: Tobradex Opthalmic SolutionThis group of randomized patients will be instructed to instill 2 gtt of Tobradex Opthalmic Solution every 6 hours for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All potential subjects with symptomatic blepharitis examined to have blepharitis with healthy mental status, able to give consent, with/without co-existing medical conditions will be considered
Key exclusion criteria (1 listed)
- All subjects with history and/or probable history of allergic reaction to tobramycin/dexamethasone and all subjects who have mental disability and are unable to give direct consent will be excluded
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 |
|---|---|---|
| Tobramycin/dexamethasone opthalmic solutionAlso: TobradexTo compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution | Drug | Tobramycin/Dexamethasone opthamic Solution |
| Tobradex Opthalmic SolutionTobradex Opthalmic Solution | Drug | Tobradex Opthalmic Solution |
Primary outcome
Sign and symptoms composite score
Time frame: 10 days
The change from baseline in the signs and symptoms score. Global sign and symptom score defined as the total score of lid margin redness (0-3), lid swelling (0-4), bulbar conjunctival redness (0-3), palpebral conjunctival redness (0-3), ocular discharge (0-3), itchy eyelids (0-4), and gritty eyes (0-4). The change from baseline to Day 10 (Visit 3 at day 1, day 7 and day 10) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Blepharo Conjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic
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.
Ajai Prakash principal investigator
Sutphin Drugs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tobramycin/dexamethasone opthalmic solution and Tobradex Opthalmic Solution in people with Blepharo Conjunctivitis, run by Sutphin Drugs at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 5 Jun 2019. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Ajai Prakash (7183260310, ajaiprakashny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sign and symptoms composite score (time frame: 10 days). 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 5 Jun 2019.