NCT02810119CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ocuwize LTD
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- The change from baseline in lissamine green conjunctival staining (LGCS) score
Study Overview
Brief Summary
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis
Detailed Description
Phase 2a, randomized, placebo-controlled, pilot study in up to 21 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 2:1 (active:placebo) ratio to one of two treatment groups, LO2A or placebo.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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
- •Use of contact lenses within 7 days of Visit
- •Punctal plug insertion within 30 days of Visit
- •Use of topical or systemic cyclosporine within 30 days of Visit
- •Use of medications known to cause ocular drying (e.g. antihistamines, sleep aids, etc.), unless at a stable dose, within 30 days of Visit
- •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.
Arms & Interventions
LO2A
Experimental
Sodium Hyaluronate
Intervention: LO2A (Drug)
Placebo-Controlled Saline
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The change from baseline in lissamine green conjunctival staining (LGCS) score
Time Frame: baseline and 3 months
Secondary Outcomes
- The change from baseline in LGCS score(baseline and 1 month)
- The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months(baseline, 1 month and 3 months])
- The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months(baseline, 1 month and 3 months)
- The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline(baseline, 1 month and 3 months)
Investigators
Study Sites (1)
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