Safety and Efficacy of TOP1630 for Dry Eye Syndrome

NCT03088605 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TOP1630-TV-04
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

In subjects with Dry Eye Syndrome: The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo. The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (10)

• Visual Acuity

  Visual Acuity will be measured using the EDTRS chart to assess changes from baseline

  Part 1: 12 days time frame; Part 2: 35 days time frame

• Slit-lamp Biomicroscopy

  Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities

  Part 1: 12 days time frame; Part 2: 35 days time frame

• Drop Comfort Assessment

  The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable

  Part 1: 12 days time frame

• Intraocular Pressure

  a non-contact tonometer will be used to perform IOP to assess changes from baseline.

  Part 1: 12 days time frame; Part 2: 35 days time frame

• Corneal Sensitivity

  The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6

  Part 1: 12 days time frame; Part 2: 35 days time frame

• Undilated Fundoscopy

  Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities

  Part 2: 35 days time frame

• Vital Signs - Pulse

  Changes in vital signs is performed to assess changes from baseline

  Part 1: 12 days time frame; Part 2: 35 days time frame

• Vital Signs - O2 Saturation

  Changes in vital signs is performed to assess changes from baseline

  Part 1: 12 days time frame; Part 2: 35 days time frame

• Vital Signs - Systolic Blood Pressure

  Changes in vital signs is performed to assess changes from baseline

  Part 1: 12 days time frame; Part 2: 35 days time frame

• Vital Signs - Diastolic Blood Pressure

  Changes in vital signs is performed to assess changes from baseline

  Part 1: 12 days time frame; Part 2: 35 days time frame

Secondary Outcomes (6)

• Ocular Discomfort

  Part 2: 35 days time frame

• Dry Eye Symptoms

  Part 2: 35 days time frame

• Dry Eye Signs

  Part 2: 35 days time frame

• Tear Film Break up Time

  Part 2: 35 days time frame

• Schirmer's Test

  Part 2: 35 days time frame

Study Arms (2)

Active

EXPERIMENTAL

TOP1630 Ophthalmic Solution

Drug: TOP1630 Ophthalmic Solution

Placebo

PLACEBO COMPARATOR

Placebo (Vehicle) Ophthalmic Solution

Drug: Placebo to TOP1630 Ophthalmic Solution

Interventions

TOP1630 Ophthalmic Solution DRUG

Bilateral ocular drug administration

Active

Placebo to TOP1630 Ophthalmic Solution DRUG

Bilateral ocular drug administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age;
• Provide written informed consent;
• Have a reported history of dry eye;
• Have a history of use of eye drops for dry eye symptoms;
• Additionally for Part 2
• Symptoms of dry eye syndrome including:
• Ocular discomfort
• Conjunctival redness
• Tear film break up time
• Schirmer test score
• Signs of dry eye syndrome including:
• Conjunctival staining score

You may not qualify if:

• Have any clinically significant slit lamp findings at entry visit ;
• Be diagnosed with an ongoing ocular infection;
• Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI;
• Have any planned ocular and/or lid surgeries over the study period;
• Have an uncontrolled systemic disease;
• Be a woman who is pregnant, nursing or planning a pregnancy;
• Be a woman of childbearing potential who is not using an acceptable means of birth control;
• Have a known allergy and/or sensitivity to the test article or its components;
• Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;

Sponsors & Collaborators

• ORA, Inc.: lead
• Topivert Pharma Ltd: collaborator

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Topivert Pharma Ltd

info@topivert.com

+44 203 763 9469

Study Officials

• G Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 23, 2017
• Study Start: February 20, 2017
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-01

Locations

US (1)