Dry EyeNCT01030237
An Evaluation of the Safety and Efficacy of FID 114657
A study testing FID 114657 and Soothe XP Lubricant Eye Drops in people with Dry Eye, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- FID 114657 and Soothe XP Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jan 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of dry eye
- NaFl Corneal Staining sum score ≥ 3 in either eye
Who cannot join
- Must not have worn contact lenses for 1 week preceding enrollment
About this study
The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.
- Conditions
- Dry Eye
- Being tested
- FID 114657, Soothe XP Lubricant Eye Drops
- Keywords
- Dry eye, artificial tears
- 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.
FID 114657Other
1 drop both eyes four times a day for 6 weeks
Soothe XP Lubricant Eye DropsOther
1 drop both eyes four times a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| FID 114657 | Experimental | FID 114657 Receives: Other: FID 114657 |
| Soothe XP Lubricant Eye Drops | Active comparator | Soothe XP Lubricant Eye Drops Receives: Other: Soothe XP Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break-Up Time (TBUT)
Measured: measured at Days 0, 7, 14, 28 and 42
Corneal Staining
Measured: measured at Days 0, 7, 14, 28 and 42
Conjunctival Staining
Measured: measured at Days 0, 7, 14, 28 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030237
- Sponsor's protocol ID
- C-07-34
- Status last verified
- Feb 2012
- First submitted
- 10 Dec 2009
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Efficacy of FID 114657
- ClinicalTrials.gov ID
- NCT01030237
- Acronym / sponsor ID
- C-07-34
- Conditions
- Dry Eye
- Keywords
- Dry eye, artificial tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- First posted
- 11 Dec 2009 (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 purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID 114657 | Experimental | Other: FID 114657FID 114657 |
| Soothe XP Lubricant Eye Drops | Active comparator | Other: Soothe XP Lubricant Eye DropsSoothe XP Lubricant Eye Drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented diagnosis of dry eye
- NaFl Corneal Staining sum score ≥ 3 in either eye
Key exclusion criteria (1 listed)
- Must not have worn contact lenses for 1 week preceding enrollment
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 |
|---|---|---|
| FID 1146571 drop both eyes four times a day for 6 weeks | Other | FID 114657 |
| Soothe XP Lubricant Eye Drops1 drop both eyes four times a day for 6 weeks | Other | Soothe XP Lubricant Eye Drops |
Primary outcome
Tear Break-Up Time (TBUT)
Time frame: measured at Days 0, 7, 14, 28 and 42
Corneal Staining
Time frame: measured at Days 0, 7, 14, 28 and 42
Conjunctival Staining
Time frame: measured at Days 0, 7, 14, 28 and 42
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 2 Feb 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing FID 114657 and Soothe XP Lubricant Eye Drops in people with Dry Eye, run by Alcon Research.
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 2 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 2 Feb 2012. 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.
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?
Tear Break-Up Time (TBUT) (time frame: measured at Days 0, 7, 14, 28 and 42). The study lists 3 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 2 Feb 2012.