Dry Eye SyndromePhase 2NCT01675570
A Study of RX-10045 in the Treatment of Dry Eye Disease
A Phase 2 study testing RX-10045 in people with Dry Eye Syndrome, run by C.T. Development America, Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- RX-10045
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2012
- Phase
- Phase 2
- 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
- Have a patient reported history of dry eye in both eyes
- Presence of dry eye symptoms
- Presence of dry eye signs, destabilized tear film break-up time and corneal staining
Who cannot join
- Known contraindications or sensitivities to study medication or its components
- Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- Use of disallowed medication during the period indicated prior to the enrollment or during the study
- Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease
The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.
- Conditions
- Dry Eye Syndrome
- Being tested
- RX-10045, Vehicle for RX-10045
- Keywords
- RX-10045, Dry Eye Disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX-10045Drug
One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
Vehicle for RX-10045Drug
One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| RX-10045 active arm | Experimental | RX-10045 Opththalmic Solution, 0.09% Receives: Drug: RX-10045 |
| Vehicle for RX-10045 arm | Placebo comparator | Vehicle of RX-10045 Ophthalmic Solution Receives: Drug: Vehicle for RX-10045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal staining
Measured: Baseline to day 28
Worst symptom score
Measured: Baseline to day 28
Secondary outcomes (3)
Ocular discomfort symptom score
Measured: Baseline to day 28
Tear film break-up time
Measured: Baseline to day 28
Visual-related function subscale of Ocular Surface Disease Index score
Measured: Baseline to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.T. Development America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675570
- Sponsor's protocol ID
- CTD1201
- Status last verified
- Feb 2013
- First submitted
- 28 Aug 2012
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01675570
- Acronym / sponsor ID
- CTD1201
- Conditions
- Dry Eye Syndrome
- Keywords
- RX-10045, Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- C.T. Development America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Aug 2012 (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.
The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RX-10045 active arm | Experimental | Drug: RX-10045RX-10045 Opththalmic Solution, 0.09% |
| Vehicle for RX-10045 arm | Placebo comparator | Drug: Vehicle for RX-10045Vehicle of RX-10045 Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a patient reported history of dry eye in both eyes
- Presence of dry eye symptoms
- Presence of dry eye signs, destabilized tear film break-up time and corneal staining
Key exclusion criteria (4 listed)
- Known contraindications or sensitivities to study medication or its components
- Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- Use of disallowed medication during the period indicated prior to the enrollment or during the study
- Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
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 |
|---|---|---|
| RX-10045One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days. | Drug | RX-10045 active arm |
| Vehicle for RX-10045One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days. | Drug | Vehicle for RX-10045 arm |
Primary outcome
Corneal staining
Time frame: Baseline to day 28
Worst symptom score
Time frame: Baseline to day 28
3 secondary outcomes
Ocular discomfort symptom score
Time frame: Baseline to day 28
Tear film break-up time
Time frame: Baseline to day 28
Visual-related function subscale of Ocular Surface Disease Index score
Time frame: Baseline to day 28
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 8 Feb 2013.
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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.
Gail Torkildsen, MD principal investigator
Andover Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RX-10045 in people with Dry Eye Syndrome, run by C.T. Development America, Inc. 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 3 inclusion and 4 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 8 Feb 2013. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Corneal staining (time frame: Baseline to day 28). 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 8 Feb 2013.