ConjunctivochalasisPhase 2NCT02804191
Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis
A Phase 2 study testing LO2A and Saline in people with Conjunctivochalasis, run by Ocuwize LTD at 3 sites in Israel.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctivochalasis
- What is being tested?
- LO2A and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 3 sitesIsrael
- Study dates
- Jul 2016to Jun 2019
- 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
- Male or female of any race and ≥ 18 years of age.
- Willing and able to provide voluntary written informed consent.
- Moderate to severe conjunctivochalasis defined by:
- LIPCOF score ≥ 2; and
- Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
- Subject has been diagnosed or treated for another malignancy within 3 years of screening, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
- A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
- Subjects with pterygium.
- Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
- Subjects with blepharitis requiring treatment.
Show all 18Show fewer
- Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
- Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
- Subjects who have used any of the following medications or treatments:
- LASIK or PRK surgery within 12 months of Visit 1.
- Use of contact lenses within 7 days of Visit 1.
- Punctal plug insertion within 30 days of Visit 1.
- Use of topical or systemic cyclosporine within 30 days of Visit 1.
- Use of medications known to cause ocular drying (e.g. antihistamines, sleep aids, etc.), unless at a stable dose, within 30 days of Visit 1.
- Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981).
- Active abuse of alcohol or drugs.
- Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
- Participation in a clinical trial of an investigational (unapproved) drug or device within 1 month prior to screening or scheduled to receive another investigational drug or device during this study
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis
Read the detailed description
Phase 2, randomized, placebo-controlled, parallel group, study in up to 62 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, stratified by LIPCOF grade at baseline.
This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).
- Conditions
- Conjunctivochalasis
- Being tested
- LO2A, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LO2ADrug
eye drop solution.
SalineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LO2A | Experimental | Sodium Hyaluronate Receives: Drug: LO2A |
| Placebo-Controlled | Placebo comparator | Saline. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in lissamine green conjunctival staining (LGCS) score.
Measured: 3 Months
Secondary outcomes (4)
The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline
Measured: 3 Months
The change from baseline in LGCS score
Measured: 1 month
The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months
Measured: 3 Months
The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConjunctivochalasisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocuwize LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Or Eisenberg, CPA, Study director, Ocuwize Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804191
- Sponsor's protocol ID
- WP-LO2A-01
- Status last verified
- Sep 2017
- First submitted
- 6 Jun 2016
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Final Data report will be publish when the study will be finalized
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis
- ClinicalTrials.gov ID
- NCT02804191
- Acronym / sponsor ID
- WP-LO2A-01
- Conditions
- Conjunctivochalasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ocuwize LTDIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 17 Jun 2016 (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.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis
Detailed description
Phase 2, randomized, placebo-controlled, parallel group, study in up to 62 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, stratified by LIPCOF grade at baseline.
This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LO2A | Experimental | Drug: LO2ASodium Hyaluronate |
| Placebo-Controlled | Placebo comparator | Drug: SalineSaline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female of any race and ≥ 18 years of age.
- Willing and able to provide voluntary written informed consent.
- Moderate to severe conjunctivochalasis defined by:
- Willing and able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (18 listed)
- Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
- Subjects with pterygium.
- Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
- Subjects with blepharitis requiring treatment.
- Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
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 |
|---|---|---|
| LO2Aeye drop solution. | Drug | LO2A |
| SalinePlacebo | Drug | Placebo-Controlled |
Primary outcome
The change from baseline in lissamine green conjunctival staining (LGCS) score.
Time frame: 3 Months
4 secondary outcomes
The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline
Time frame: 3 Months
The change from baseline in LGCS score
Time frame: 1 month
The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months
Time frame: 3 Months
The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months
Time frame: 3 Months
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 25 Feb 2021.
- Individual participant dataSharing planned: Undecided. Final Data report will be publish when the study will be finalized
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.
Or Eisenberg, CPA study director
Ocuwize Pharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LO2A and Saline in people with Conjunctivochalasis, run by Ocuwize LTD at 3 sites in Israel.
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 6 inclusion and 18 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
The change from baseline in lissamine green conjunctival staining (LGCS) score. (time frame: 3 Months). 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 25 Feb 2021.