Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on adults with impaired dark adaptation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Benefit and Tolerability of IQP-AE-103 in Weight Loss

NCT03058367

Overweight Obesity

COMPLETED NA

Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity

NCT03287960

Leptin Receptor Deficiency Obesity

COMPLETED PHASE3

Benefit and Tolerability of IQP-LU-104 in Weight Loss

NCT03888911

Overweight Obesity

COMPLETED NA

A Study of Eloralintide (LY3841136) in Chinese Participants With Obesity or Overweight

NCT06916091

Obesity Overweight

COMPLETED PHASE1

Long Term Extension Trial of Setmelanotide

NCT03651765

Obesity Associated With Defects in Leptin-melanocortin Pathway

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This proof-of-concept study is a randomized, parallel design of two different oral doses of QLT091001 compared to placebo to evaluate treatment effects in patients with impaired dark adaptation.

Approximately 40 subjects will be enrolled in this study at approximately 7 centers in the US.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impaired Dark Adaptation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo (for QLT091001)

Placebo is supplied to mimic QLT091001 oral solution.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo is administered orally at multiple time points.

QLT091001 - first oral dose

Subjects will receive an oral dose of 10mg/m2 of QLT091001.

Group Type EXPERIMENTAL

QLT091001

Intervention Type DRUG

QLT091001 administered orally at multiple time points.

QLT091001 - second oral dose

Subjects will receive an oral dose of 40 mg/m2 of QLT091001.

Group Type EXPERIMENTAL

QLT091001

Intervention Type DRUG

QLT091001 administered orally at multiple time points.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QLT091001

QLT091001 administered orally at multiple time points.

Intervention Type DRUG

Placebo

Placebo is administered orally at multiple time points.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female subjects ≥60 yrs with early age-related macular degeneration (AMD) based on LLLC BCVA criterion or evidence of impaired dark adaptation
* Subjects with high luminance high contrast best-corrected visual acuity (HLHC BCVA) of 40 letters (20/40 Snellen) or better in the study eye
* Capable and willing to provide consent

Exclusion Criteria

* Women of child bearing potential
* Subjects with late AMD or any other optic neuropathy in the study eye
* Subjects with posterior subcapsular cataract or multifocal intra-ocular lens (IOL) in the study eye
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of Day 0 or who have taken any prescription/investigational oral retinoid medication within 6 months of Day 0
* Subjects taking age-related eye disease study (AREDS) supplements containing beta-carotene

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No