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NCT02617667 · ClinicalTrials.gov registry record · Phase 2
CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)
A Phase 2 study of Dry Eye Syndromes, sponsored by Novaliq.
- Completed
- Registry status
- Phase 2
- Development phase
- 207
- Enrollment target
- 4
- Study locations
NCT02617667: Completed Phase 2 study of Dry Eye Syndromes, sponsored by Novaliq.
NCT02617667 is a Phase 2 study of Dry Eye Syndromes that has completed, run by Novaliq. The registered enrollment target is 207 participants, below the 402-participant average among 17 other Dry Eye Syndromes trials with a reported enrollment target (49% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02617667, a Phase 2 study of Dry Eye Syndromes, has completed, sponsored by Novaliq.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 207 participants
- Enrollment target
- 4
- Study locations
Study Summary
The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).
Primary Outcome
The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cyclosporine A
Study Locations (4)
Massachusetts
- CYS-002 Investigational Site - Andover
- CYS-002 Investigational Site - Quincy
California
- CYS-002 Investigational Site - Newport Beach
Maine
- CYS-002 Investigational Site - Lewiston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT02617667 record still lists
NCT02617667 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 402-participant average among 17 other Dry Eye Syndromes trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Dry Eye Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02617667 reports a single indexed study location in Massachusetts, California, Maine.
Frequently Asked Questions
What is clinical trial NCT02617667 about?
NCT02617667 is a clinical study titled "CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)". The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).
What is the current status of trial NCT02617667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2016-01. Estimated completion is 2016-09.
What conditions does trial NCT02617667 study?
This clinical trial studies the following conditions: Dry Eye Syndromes.
What interventions are being tested in trial NCT02617667?
The interventions under investigation include: Placebo (DRUG), Cyclosporine A (DRUG).
Who is sponsoring clinical trial NCT02617667?
This trial is sponsored by Novaliq, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02617667 being conducted?
This trial has 4 study locations across California, Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02617667's enrollment target sits among peer trials
207 6th of 17 higher than 12 of 17 other Dry Eye Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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