Dry Eye SyndromesPhase 3NCT02455050
A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief
A Phase 3 study testing Carboxymethylcellulose Sodium Based Eye Drops, Systane® Gel Drops and Genteal® Lubricant Gel Drops in people with Dry Eye Syndromes, run by Allergan at 1 site in United States.
Trial summary
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation 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 Syndromes
- What is being tested?
- Carboxymethylcellulose Sodium Based Eye Drops, Systane® Gel Drops and Genteal® Lubricant Gel Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Current use of an artificial tear product
- Visual Acuity of at least 20/40 (while wearing glasses, if necessary).
Who cannot join
- Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy within 6 months
- Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months
- Diagnosis of glaucoma.
Trial locations and contacts
1 site in 1 country.
About this study
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- Carboxymethylcellulose Sodium Based Eye Drops, Systane® Gel Drops, Genteal® Lubricant Gel Drops
- 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.
Carboxymethylcellulose Sodium Based Eye DropsDrug
1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.
Systane® Gel DropsDrug
Also called 1 to 2 drops of Systane® Gel Drops in each eye daily.
1 to 2 drops of Systane® Gel Drops in each eye.
Genteal® Lubricant Gel DropsDrug
1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.
| Study group | Role | What they receive |
|---|---|---|
| New Eye Drop Formulation then Systane® | Other | 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks. Receives: Drug: Carboxymethylcellulose Sodium Based Eye Drops; Drug: Systane® Gel Drops |
| Systane® then New Eye Drop Formulation | Other | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. Receives: Drug: Carboxymethylcellulose Sodium Based Eye Drops; Drug: Systane® Gel Drops |
| Genteal® then New Eye Drop Formulation | Other | 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. Receives: Drug: Carboxymethylcellulose Sodium Based Eye Drops; Drug: Genteal® Lubricant Gel Drops |
| New Eye Drop Formulation then Genteal® | Other | 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks. Receives: Drug: Carboxymethylcellulose Sodium Based Eye Drops; Drug: Genteal® Lubricant Gel Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1
Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).
Measured: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2
Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).
Measured: After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Secondary outcomes (14)
Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1
The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.
Measured: Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2
The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.
Measured: Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1
Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.
Measured: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2
Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.
Measured: After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1
SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).
Measured: Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2
SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).
Measured: Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)
End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.
Measured: Day 35
Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)
End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.
Measured: Day 35
Distance Visual Acuity in Period 1
Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).
Measured: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Distance Visual Acuity in Period 2
Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).
Measured: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Tear Break-Up Time With Fluorescein in Period 1
Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.
Measured: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Tear Break-Up Time With Fluorescein in Period 2
Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.
Measured: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1
Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.
Measured: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2
Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.
Measured: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455050
- Sponsor's protocol ID
- 11193X-002
- Status last verified
- Nov 2016
- First submitted
- 22 Jan 2015
- Last updated
- 4 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief
- ClinicalTrials.gov ID
- NCT02455050
- Acronym / sponsor ID
- 11193X-002
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| New Eye Drop Formulation then Systane® | Other | Drug: Carboxymethylcellulose Sodium Based Eye Drops, Drug: Systane® Gel Drops1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks. |
| Systane® then New Eye Drop Formulation | Other | Drug: Carboxymethylcellulose Sodium Based Eye Drops, Drug: Systane® Gel Drops1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. |
| Genteal® then New Eye Drop Formulation | Other | Drug: Carboxymethylcellulose Sodium Based Eye Drops, Drug: Genteal® Lubricant Gel Drops1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. |
| New Eye Drop Formulation then Genteal® | Other | Drug: Carboxymethylcellulose Sodium Based Eye Drops, Drug: Genteal® Lubricant Gel Drops1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current use of an artificial tear product
- Visual Acuity of at least 20/40 (while wearing glasses, if necessary).
Key exclusion criteria (4 listed)
- Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy within 6 months
- Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months
- Diagnosis of glaucoma.
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 |
|---|---|---|
| Carboxymethylcellulose Sodium Based Eye Drops1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye. | Drug | Genteal® then New Eye Drop Formulation, New Eye Drop Formulation then Genteal®, New Eye Drop Formulation then Systane®, Systane® then New Eye Drop Formulation |
| Systane® Gel DropsAlso: 1 to 2 drops of Systane® Gel Drops in each eye daily.1 to 2 drops of Systane® Gel Drops in each eye. | Drug | New Eye Drop Formulation then Systane®, Systane® then New Eye Drop Formulation |
| Genteal® Lubricant Gel Drops1 to 2 drops of Genteal® Lubricant Gel Drops in each eye. | Drug | Genteal® then New Eye Drop Formulation, New Eye Drop Formulation then Genteal® |
Primary outcome
Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).
Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).
14 secondary outcomes
Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1
Time frame: Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2
Time frame: Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1
Time frame: Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)
Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2
Time frame: Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)
Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)
Time frame: Day 35
Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)
Time frame: Day 35
Distance Visual Acuity in Period 1
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Distance Visual Acuity in Period 2
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Tear Break-Up Time With Fluorescein in Period 1
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Tear Break-Up Time With Fluorescein in Period 2
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1
Time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation
Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2
Time frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carboxymethylcellulose Sodium Based Eye Drops, Systane® Gel Drops and Genteal® Lubricant Gel Drops in people with Dry Eye Syndromes, run by Allergan 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 2 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 4 Jan 2017. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 (time frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14)). 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 4 Jan 2017.