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IC265 Eye Drops for Dry Eye Syndrome
Phase 2
Recruiting
Research Sponsored by Iacta Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 15, 43 and 85 and mean change from day 1 to day 85
Awards & highlights
Study Summary
This trial will test a new drug to treat dry eye symptoms. It will check how safe and effective it is.
Who is the study for?
Adults with dry eye disease who have used or wanted to use eye drops for symptoms within the last 6 months. They must have certain scores on tests measuring tear production and eye redness, and a history of dry eyes for at least 6 months. People can't join if they've had recent eye surgery, wear contact lenses, or have other significant eye conditions.Check my eligibility
What is being tested?
The trial is testing IC265 Ophthalmic Solution against a placebo solution to see if it's safe and effective in treating signs and symptoms of dry eye syndrome in adults.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions associated with ophthalmic solutions such as irritation, discomfort, redness, or blurred vision.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 15, 43 and 85 and mean change from day 1 to day 85
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 15, 43 and 85 and mean change from day 1 to day 85
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Conjunctival Redness
Daily Diary Symptom Score
Fluorescein staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IC265 Ophthalmic Solution 1%Experimental Treatment1 Intervention
1 drop will be instilled in each eye twice daily.
Group II: Placebo Ophthalmic Solution (Vehicle)Placebo Group1 Intervention
1 drop will be instilled in each eye twice daily.
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Who is running the clinical trial?
Iacta PharmaceuticalsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no significant eye issues needing treatment.I have had or will have tear duct surgery or plugs inserted/removed recently.I have had dry eye symptoms for at least 6 months.I have used or wanted to use eye drops for dry eyes in the last 6 months.I am 18 years old or older.I haven't used and don't plan to use certain treatments during the study.I have or had serious eye conditions that needed treatment.I have used or plan to use temporary eye tear duct plugs recently.My eye dryness test score is between 1mm and 10mm.I have not had LASIK or any eye surgery in the last year and no plans for it during the study.I have not had eye or eyelid surgery in the last 6 months.I have had a blocked tear duct in the past year.I reported moderate to severe eye discomfort on a recent questionnaire.I have experienced eye discomfort of level 3 or higher during tests.My eye test shows significant staining in at least one area.My eye redness score is 1 or higher in at least one eye.
Research Study Groups:
This trial has the following groups:- Group 1: IC265 Ophthalmic Solution 1%
- Group 2: Placebo Ophthalmic Solution (Vehicle)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has IC265 Ophthalmic Solution 1% been given the greenlight by the FDA?
"There is evidence verifying the safety of IC265 Ophthalmic Solution 1%, so it received a rating of 2. Nevertheless, efficacy has not been established yet due to this being only Phase 2 in clinical trials."
Answered by AI
Are there any current openings for participation in this clinical experiment?
"This trial, which was initially posted on November 1st 2023 and subsequently updated on August 8th of the same year is not recruiting patients at this time. However, there are 81 other studies actively searching for volunteers."
Answered by AI
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