Contact Lens Related Dry Eye SyndromePhase 4NCT01543061
Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
A Phase 4 study testing OPTIVEtm Plus, No treatment and Blink Contacts® Eye Drops in people with Contact Lens Related Dry Eye Syndrome, run by Optometric Technology Group Ltd at 1 site in United Kingdom.
Trial summary
The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Related Dry Eye Syndrome
- What is being tested?
- OPTIVEtm Plus, No treatment and Blink Contacts® Eye Drops
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 4
- 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
- Current silicone hydrogel contact lens wearer
- Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)
Who cannot join
- Known allergy or sensitivity to the study product(s) or its components
- Systemic or ocular allergies
- Use of systemic medication which might have ocular side effects.
- Any ocular infection.
- Use of ocular medication.
- Significant ocular tissue anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.
- Conditions
- Contact Lens Related Dry Eye Syndrome
- Being tested
- OPTIVEtm Plus, No treatment, Blink Contacts® Eye Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIVEtm PlusDevice
1 drop in each eye four times a day for a period of 30 (± 3) days
No treatmentProcedure or surgery
One month of contact lens wear with no eye drop use
Blink Contacts® Eye DropsDevice
Also called Blink Contacts®
1 drop in each eye four times a day for a period of 30 (± 3) days
| Study group | Role | What they receive |
|---|---|---|
| New study eye drop | Active comparator | One month of contact lens wear with use of the Test study eye drops Receives: Device: OPTIVEtm Plus |
| No Eyedrop | Placebo comparator | One month of contact lens wear with no eye drop use Receives: Procedure: No treatment |
| BLINK Contacts Lubricating eye drop | Active comparator | One month of contact lens wear with use of the Control study eye drops Receives: Device: Blink Contacts® Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break up Time
Measured: 30 days
Secondary outcomes (5)
Conjunctival staining measurement
Measured: 30 days
Tear film evaporation rate
Measured: 30 days
Ocular Surface Disease Index questionnaire
Measured: 30 days
Comfort, vision and ocular symptoms questionnaire
Measured: 30 days
Post wear contact lens deposition and lipid uptake assessment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens Related 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optometric Technology Group Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Michel Guillon, PhD, Principal investigator, Optometric Technology Group Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543061
- Sponsor's protocol ID
- AG9965-006 ID 11-19
- Status last verified
- Sep 2013
- First submitted
- 22 Feb 2012
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
- ClinicalTrials.gov ID
- NCT01543061
- Acronym / sponsor ID
- AG9965-006 ID 11-19
- Conditions
- Contact Lens Related Dry Eye Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Optometric Technology Group LtdUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Mar 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 objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New study eye drop | Active comparator | Device: OPTIVEtm PlusOne month of contact lens wear with use of the Test study eye drops |
| No Eyedrop | Placebo comparator | Procedure: No treatmentOne month of contact lens wear with no eye drop use |
| BLINK Contacts Lubricating eye drop | Active comparator | Device: Blink Contacts® Eye DropsOne month of contact lens wear with use of the Control study 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)
- Current silicone hydrogel contact lens wearer
- Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)
Key exclusion criteria (6 listed)
- Known allergy or sensitivity to the study product(s) or its components
- Systemic or ocular allergies
- Use of systemic medication which might have ocular side effects.
- Any ocular infection.
- Use of ocular medication.
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 |
|---|---|---|
| OPTIVEtm Plus1 drop in each eye four times a day for a period of 30 (± 3) days | Device | New study eye drop |
| No treatmentOne month of contact lens wear with no eye drop use | Procedure or surgery | No Eyedrop |
| Blink Contacts® Eye DropsAlso: Blink Contacts®1 drop in each eye four times a day for a period of 30 (± 3) days | Device | BLINK Contacts Lubricating eye drop |
Primary outcome
Tear Break up Time
Time frame: 30 days
5 secondary outcomes
Conjunctival staining measurement
Time frame: 30 days
Tear film evaporation rate
Time frame: 30 days
Ocular Surface Disease Index questionnaire
Time frame: 30 days
Comfort, vision and ocular symptoms questionnaire
Time frame: 30 days
Post wear contact lens deposition and lipid uptake assessment
Time frame: 30 days
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 Sep 2013.
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.
Michel Guillon, PhD principal investigator
Optometric Technology Group Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OPTIVEtm Plus, No treatment and Blink Contacts® Eye Drops in people with Contact Lens Related Dry Eye Syndrome, run by Optometric Technology Group Ltd at 1 site in United Kingdom.
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 6 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 Sep 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 Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Tear Break up Time (time frame: 30 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 27 Sep 2013.